Cardiovascular DiseasesICE-ACCESSNCT07788040
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
An observational study of Cardiovascular Diseases and Arrhythmias, Cardiac, run by Truway Health, Inc. at 1 site in United States.
Trial summary
The ICE-ACCESS study is a prospective observational study designed to evaluate how procurement reliability, distribution restrictions, supply-chain interruptions, and device availability affect access to intracardiac echocardiography (ICE) catheters and related clinical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Arrhythmias, Cardiac, Atrial Fibrillation
- What is being tested?
- Intracardiac Echocardiography Catheter
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing or scheduled for electrophysiology, cardiac ablation, structural heart, or related cardiovascular procedures in which an intracardiac echocardiography catheter is clinically relevant. Participants will be classified according to whether the associated ICE catheter procurement episode involves a documented access disruption or timely device availability. The population may include individuals associated with procurement events involving original-manufacturer or legally reprocessed ICE catheter products. Clinical treatment decisions remain independent of study participation.
Who may be able to join
- Age 18 years or older.
- Participant is scheduled for, referred for, or undergoing an electrophysiology, cardiac ablation, structural heart, or other cardiovascular procedure for which intracardiac echocardiography or an ICE catheter is clinically planned, requested, considered, or utilized.
- A documented ICE-catheter procurement or device-access episode can be identified and evaluated under the study protocol.
- Sufficient procurement, scheduling, clinical, or administrative information is available to determine device-access timing and study outcomes.
- Participant falls within either the documented ICE catheter access-disruption cohort or the timely-access comparison cohort.
- Able to provide informed consent when prospective consent is required by the applicable IRB determination, or eligible for inclusion under an IRB-approved waiver or alteration of consent where applicable.
Who cannot join
- Younger than 18 years of age.
- No planned, requested, or clinically relevant intracardiac echocardiography catheter involvement in the associated cardiovascular procedure.
- Procurement or clinical records are insufficient to establish the timing or final disposition of the device-access episode.
- Device access occurred outside the predefined study observation period.
- Procedure delay or cancellation is clearly attributable solely to an unrelated clinical or administrative circumstance and no qualifying ICE catheter access event occurred.
- Participation would conflict with another protocol, institutional restriction, or applicable human-subject protection requirement.
- Individuals for whom required authorization, consent, or permitted IRB-approved waiver criteria are not satisfied.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Observational Evaluation of Procurement Reliability, Distribution Restrictions, Supply-Chain Disruptions, and Clinical Access to Intracardiac Echocardiography Catheters
The ICE-ACCESS study is a prospective observational study designed to evaluate how procurement reliability, distribution restrictions, supply-chain interruptions, and device availability affect access to intracardiac echocardiography (ICE) catheters and related clinical care. The study will document real-world procurement attempts, fulfillment outcomes, order delays, cancellations, product substitutions, distributor restrictions, acquisition timelines, and other supply-access events involving ICE catheter devices.
Where participant-level clinical data are available under the approved protocol, the study will also examine whether device-access problems are associated with procedure delays, rescheduling, changes in planned device use, alternative sourcing, increased administrative burden, or other measurable effects on care delivery.
The study does not assign participants to a device or treatment and does not alter clinical decision-making. Procurement and clinical events are observed as they occur in routine practice. The study is intended to develop a structured evidence base for understanding the reliability of the medical-device supply chain and the potential relationship between procurement disruption and timely access to cardiovascular procedures.
Read the detailed description
Intracardiac echocardiography catheters are specialized medical devices used to provide real-time intracardiac imaging during selected electrophysiology, structural heart, and other cardiovascular procedures. Timely access to these devices may depend on a network of manufacturers, reprocessors, distributors, purchasing organizations, healthcare facilities, logistics providers, and other supply-chain participants.
ICE-ACCESS is designed to systematically characterize real-world access to intracardiac echocardiography catheters by recording procurement and fulfillment events over the study period. The protocol focuses on objectively measurable events rather than presuming that any supplier, manufacturer, distributor, or other organization is responsible for a particular outcome.
Study observations may include:
Date and time of an initial procurement request. Device manufacturer, model, catalog number, size, configuration, and regulatory status when available.
Quantity requested. Supplier or distributor contacted. Quotation availability and quotation response time. Representations regarding inventory or product availability. Account-eligibility or purchasing restrictions communicated to the purchaser. Order acceptance or rejection. Order confirmation and subsequent cancellation. Allocation or back-order status. Estimated and actual fulfillment dates. Shipping and logistics delays. Changes in purchase price or acquisition terms. Requests for purchaser qualification or supporting documentation. Product substitutions or alternative device sourcing. Number of sourcing attempts required to obtain the requested device. Administrative time required to resolve an access issue. Final procurement disposition.
The study may compare procurement events according to device type, supplier category, manufacturer, reprocessed versus original-manufacturer product status, acquisition channel, geographic region, purchasing pathway, or other predefined supply-chain characteristics.
For participants whose clinical pathway is associated with a documented device-access event, protocol-authorized data may be used to evaluate health-system or procedural consequences. These observations may include the interval between planned and actual procedures, procedure rescheduling, postponement, cancellation, use of an alternative device, changes in procedure planning, additional sourcing requirements, and other predefined measures of clinical-access disruption.
The protocol does not require the treating clinician to select a particular ICE catheter. Clinical decisions remain under the control of the treating healthcare professionals and are not dictated by the study. The study does not experimentally withhold a device, create an artificial shortage, intentionally delay a procedure, or direct suppliers to deny or restrict access.
A central objective is to distinguish among different categories of supply-chain events, including routine inventory limitations, logistical delays, commercial purchasing restrictions, account-qualification requirements, manufacturer or distributor allocation policies, order-processing failures, cancellations, product discontinuation, and other documented reasons for non-fulfillment.
Source documentation may include purchase requests, purchase orders, quotations, invoices, supplier correspondence, distributor communications, order confirmations, cancellation notices, shipping records, catalog information, product identifiers, device availability records, and other contemporaneous procurement documentation. When permitted under the protocol, relevant clinical scheduling or procedural records may also be reviewed to establish the timing and consequence of a documented access event.
Each event may be assigned a standardized study identifier and chronology so that the sequence from initial device request through final disposition can be reconstructed. Electronic integrity controls, including document hashing, serialized event identifiers, audit trails, and controlled versioning, may be used to preserve the provenance of research records. These controls are intended to support research data integrity and do not independently establish legal liability or regulatory noncompliance.
Potential study endpoints include successful procurement rate, time to confirmed fulfillment, time to delivery, cancellation rate, restriction rate, substitution rate, number of sourcing attempts, acquisition-price variability, administrative burden, and the frequency and duration of associated procedure delays.
Exploratory analyses may assess whether particular procurement characteristics are associated with increased time to fulfillment or a higher probability of an access disruption. Analyses may also evaluate patterns of repeated non-fulfillment, variation among supply channels, and differences between represented product availability and documented procurement outcomes.
The study is observational and is intended to characterize medical-device access and supply-chain reliability using systematically collected data. Findings may inform healthcare procurement practices, supply-chain resilience strategies, quality-improvement activities, future clinical-access research, and evaluation of medical-device availability without predetermining the conduct or liability of any particular organization.
- Being tested
- Intracardiac Echocardiography Catheter
- Keywords
- Intracardiac echocardiography, ICE catheter, AcuNav, Intracardiac ultrasound, Electrophysiology, Cardiac ablation, Structural heart procedures, Medical device availability, Medical device procurement, Supply chain disruption, Healthcare supply chain, Distributor restrictions, Order fulfillment, Procurement delay, Procedure delay, Procedure rescheduling, Device substitution, Alternative sourcing, Clinical access, Healthcare delivery
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac Echocardiography CatheterDevice
Also called ICE Catheter; Intracardiac Ultrasound Catheter; AcuNav
A U.S. FDA-regulated intracardiac echocardiography catheter used to provide real-time intracardiac ultrasound imaging during electrophysiology, cardiac ablation, structural heart, and related cardiovascular procedures. The study does not assign participants to a particular catheter or alter clinical treatment. Instead, it prospectively observes access to the device, including availability, procurement, fulfillment, substitution, and supply-chain disruption, and evaluates associated effects on procedural access and healthcare delivery.
| Study group | Role | What they receive |
|---|---|---|
| ICE Catheter Access Disruption Cohort | Participants whose planned electrophysiology, cardiac ablation, structural heart, or other cardiovascular care involves a documented disruption in access to an intracardiac echocardiography catheter. Qualifying events may include procurement delay, supplier non-fulfillment, order cancellation, backorder, allocation, purchasing restriction, distribution restriction, shipment delay, or required substitution of the originally requested ICE catheter. Participants are observed prospectively for device-access timelines and associated procedural or healthcare-delivery outcomes. Receives: Device: Intracardiac Echocardiography Catheter | |
| Timely ICE Catheter Access Cohort | Participants undergoing comparable cardiovascular procedures for whom the required intracardiac echocardiography catheter is available and obtained without a qualifying procurement or supply-chain disruption. This cohort serves as the observational comparison group for evaluating time to procedure, rescheduling, device substitution, procurement burden, and other predefined healthcare-delivery outcomes. Receives: Device: Intracardiac Echocardiography Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful ICE Catheter Procurement
Number of calendar days from the initial documented request for an intracardiac echocardiography catheter to confirmed procurement or fulfillment of the requested device. The measure will be compared between participants associated with a documented device-access disruption and participants with timely device access.
Measured: From initial procurement request through device fulfillment, up to 90 days
Incidence of ICE Catheter Supply-Chain Disruption
Proportion of observed procurement episodes experiencing at least one predefined supply-chain disruption, including order rejection, cancellation, backorder, allocation, distributor restriction, shipment delay, non-fulfillment, or required substitution of the requested ICE catheter.
Measured: From initial procurement request through final procurement disposition, up to 90 days
Procedure Delay Associated With ICE Catheter Access
Number and proportion of participants whose planned cardiovascular or electrophysiology procedure is delayed, rescheduled, or otherwise deferred following a documented disruption in access to the required intracardiac echocardiography catheter.
Measured: From planned procedure scheduling through completion of the procedure, up to 90 days
Secondary outcomes (8)
Time From Planned to Actual Procedure
Number of calendar days between the originally scheduled procedure date and the date the procedure is ultimately performed.
Measured: Up to 90 days
Rate of Procedure Rescheduling or Cancellation
Proportion of participants whose planned cardiovascular or electrophysiology procedure is rescheduled or cancelled during the observation period, with events classified according to whether a documented ICE catheter access disruption was present.
Measured: Up to 90 days from the originally scheduled procedure date
ICE Catheter Device Substitution Rate
Proportion of procurement episodes in which the originally requested ICE catheter is replaced with an alternative manufacturer, model, size, reprocessed device, or other clinically acceptable substitute because the requested device could not be obtained as planned.
Measured: From initial procurement request through procedure completion, up to 90 days
Number of Procurement Attempts Required for Successful Device Access
Total number of documented supplier, distributor, manufacturer, or alternative-source procurement attempts required before the necessary ICE catheter is successfully obtained or the procurement episode is closed without fulfillment.
Measured: From initial procurement request through final disposition, up to 90 days
ICE Catheter Order Non-Fulfillment Rate
Proportion of submitted procurement requests that are not fulfilled as originally requested because of cancellation, rejection, lack of inventory, purchasing restriction, allocation, distribution limitation, or another documented reason.
Measured: Up to 90 days following each procurement request
Procurement Administrative Burden
Total documented number of procurement-related contacts, communications, sourcing attempts, account-verification actions, or administrative escalation events required to obtain an ICE catheter or reach final procurement disposition.
Measured: From initial procurement request through final disposition, up to 90 days
Mean Difference Between Initially Quoted and Final ICE Catheter Acquisition Cost
For each completed procurement episode, the final documented acquisition cost minus the initially quoted or expected acquisition cost will be calculated in U.S. dollars. The outcome will be reported as the mean difference across evaluable procurement episodes. Positive values indicate a higher final cost, and negative values indicate a lower final cost. Episodes without both an initial and final cost will not be included in this outcome.
Measured: From initial quotation through final acquisition, up to 90 days
Time to Alternative Device Sourcing
Number of calendar days from determination that the originally requested ICE catheter cannot be obtained as planned to confirmation of an alternative clinically acceptable device source.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start23 Oct 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Truway Health, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Truway Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gavin C Solomon, MD, Principal investigator, Truway Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788040
- Sponsor's protocol ID
- TH-ICEACCESS-2026-001
- Acronym
- ICE-ACCESS
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study may incorporate confidential clinical, procurement, contractual, commercial, and supply-chain information. Aggregate or appropriately de-identified findings may be reported in publications, regulatory communications, or research summaries consistent with applicable privacy requirements, IRB authorization, and data-use restrictions.
Publications
Dravid SG, Hope B, McKinnie JJ. Intracardiac echocardiography in electrophysiology: a review of current applications in practice. Echocardiography. 2008 Nov;25(10):1172-5. doi: 10.1111/j.1540-8175.2008.00784.x.
PubMed 18986404Isath A, Padmanabhan D, Haider SW, Siroky G, Perimbeti S, Correa A, Chahal CAA, Shenthar J, Asirvatham S, Mehta D. Does the use of intracardiac echocardiography during atrial fibrillation catheter ablation improve outcomes and cost? A nationwide 14-year analysis from 2001 to 2014. J Interv Card Electrophysiol. 2021 Sep;61(3):461-468. doi: 10.1007/s10840-020-00844-5. Epub 2020 Aug 2.
PubMed 32743700Enriquez A, Saenz LC, Rosso R, Silvestry FE, Callans D, Marchlinski FE, Garcia F. Use of Intracardiac Echocardiography in Interventional Cardiology: Working With the Anatomy Rather Than Fighting It. Circulation. 2018 May 22;137(21):2278-2294. doi: 10.1161/CIRCULATIONAHA.117.031343.
PubMed 29784681Alyesh D, Choe W, Demo H, Razminia M, Sundaram S. The Advanced Application of Intracardiac Echocardiography for Cardiac Electrophysiology Ablation Procedures. Curr Cardiol Rep. 2022 May;24(5):505-511. doi: 10.1007/s11886-022-01672-x. Epub 2022 Mar 9.
PubMed 35260997Gianni C, Sanchez JE, Della Rocca DG, Al-Ahmad A, Horton RP, Di Biase L, Natale A. Intracardiac Echocardiography to Guide Catheter Ablation of Atrial Fibrillation. Card Electrophysiol Clin. 2021 Jun;13(2):303-311. doi: 10.1016/j.ccep.2021.03.009. Epub 2021 Apr 23.
PubMed 33990269
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Evaluation of Procurement Reliability, Distribution Restrictions, Supply-Chain Disruptions, and Clinical Access to Intracardiac Echocardiography Catheters
- ClinicalTrials.gov ID
- NCT07788040
- Acronym / sponsor ID
- ICE-ACCESS / TH-ICEACCESS-2026-001
- Keywords
- Intracardiac echocardiography, ICE catheter, AcuNav, Intracardiac ultrasound, Electrophysiology, Cardiac ablation, Structural heart procedures, Medical device availability
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Truway Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ICE-ACCESS study is a prospective observational study designed to evaluate how procurement reliability, distribution restrictions, supply-chain interruptions, and device availability affect access to intracardiac echocardiography (ICE) catheters and related clinical care. The study will document real-world procurement attempts, fulfillment outcomes, order delays, cancellations, product substitutions, distributor restrictions, acquisition timelines, and other supply-access events involving ICE catheter devices.
Where participant-level clinical data are available under the approved protocol, the study will also examine whether device-access problems are associated with procedure delays, rescheduling, changes in planned device use, alternative sourcing, increased administrative burden, or other measurable effects on care delivery.
The study does not assign participants to a device or treatment and does not alter clinical decision-making. Procurement and clinical events are observed as they occur in routine practice. The study is intended to develop a structured evidence base for understanding the reliability of the medical-device supply chain and the potential relationship between procurement disruption and timely access to cardiovascular procedures.
Detailed description
Intracardiac echocardiography catheters are specialized medical devices used to provide real-time intracardiac imaging during selected electrophysiology, structural heart, and other cardiovascular procedures. Timely access to these devices may depend on a network of manufacturers, reprocessors, distributors, purchasing organizations, healthcare facilities, logistics providers, and other supply-chain participants.
ICE-ACCESS is designed to systematically characterize real-world access to intracardiac echocardiography catheters by recording procurement and fulfillment events over the study period. The protocol focuses on objectively measurable events rather than presuming that any supplier, manufacturer, distributor, or other organization is responsible for a particular outcome.
Study observations may include:
Date and time of an initial procurement request. Device manufacturer, model, catalog number, size, configuration, and regulatory status when available.
Quantity requested. Supplier or distributor contacted. Quotation availability and quotation response time. Representations regarding inventory or product availability. Account-eligibility or purchasing restrictions communicated to the purchaser. Order acceptance or rejection. Order confirmation and subsequent cancellation. Allocation or back-order status. Estimated and actual fulfillment dates. Shipping and logistics delays. Changes in purchase price or acquisition terms. Requests for purchaser qualification or supporting documentation. Product substitutions or alternative device sourcing. Number of sourcing attempts required to obtain the requested device. Administrative time required to resolve an access issue. Final procurement disposition.
The study may compare procurement events according to device type, supplier category, manufacturer, reprocessed versus original-manufacturer product status, acquisition channel, geographic region, purchasing pathway, or other predefined supply-chain characteristics.
For participants whose clinical pathway is associated with a documented device-access event, protocol-authorized data may be used to evaluate health-system or procedural consequences. These observations may include the interval between planned and actual procedures, procedure rescheduling, postponement, cancellation, use of an alternative device, changes in procedure planning, additional sourcing requirements, and other predefined measures of clinical-access disruption.
The protocol does not require the treating clinician to select a particular ICE catheter. Clinical decisions remain under the control of the treating healthcare professionals and are not dictated by the study. The study does not experimentally withhold a device, create an artificial shortage, intentionally delay a procedure, or direct suppliers to deny or restrict access.
A central objective is to distinguish among different categories of supply-chain events, including routine inventory limitations, logistical delays, commercial purchasing restrictions, account-qualification requirements, manufacturer or distributor allocation policies, order-processing failures, cancellations, product discontinuation, and other documented reasons for non-fulfillment.
Source documentation may include purchase requests, purchase orders, quotations, invoices, supplier correspondence, distributor communications, order confirmations, cancellation notices, shipping records, catalog information, product identifiers, device availability records, and other contemporaneous procurement documentation. When permitted under the protocol, relevant clinical scheduling or procedural records may also be reviewed to establish the timing and consequence of a documented access event.
Each event may be assigned a standardized study identifier and chronology so that the sequence from initial device request through final disposition can be reconstructed. Electronic integrity controls, including document hashing, serialized event identifiers, audit trails, and controlled versioning, may be used to preserve the provenance of research records. These controls are intended to support research data integrity and do not independently establish legal liability or regulatory noncompliance.
Potential study endpoints include successful procurement rate, time to confirmed fulfillment, time to delivery, cancellation rate, restriction rate, substitution rate, number of sourcing attempts, acquisition-price variability, administrative burden, and the frequency and duration of associated procedure delays.
Exploratory analyses may assess whether particular procurement characteristics are associated with increased time to fulfillment or a higher probability of an access disruption. Analyses may also evaluate patterns of repeated non-fulfillment, variation among supply channels, and differences between represented product availability and documented procurement outcomes.
The study is observational and is intended to characterize medical-device access and supply-chain reliability using systematically collected data. Findings may inform healthcare procurement practices, supply-chain resilience strategies, quality-improvement activities, future clinical-access research, and evaluation of medical-device availability without predetermining the conduct or liability of any particular organization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICE Catheter Access Disruption Cohort | – | Device: Intracardiac Echocardiography CatheterParticipants whose planned electrophysiology, cardiac ablation, structural heart, or other cardiovascular care involves a documented disruption in access to an intracardiac echocardiography catheter. Qualifying events may include procurement delay, supplier non-fulfillment, order cancellation, backorder, allocation, purchasing restriction, distribution restriction, shipment delay, or required substitution of the originally requested ICE catheter. Participants are observed prospectively for device-access timelines and associated procedural or healthcare-delivery outcomes. |
| Timely ICE Catheter Access Cohort | – | Device: Intracardiac Echocardiography CatheterParticipants undergoing comparable cardiovascular procedures for whom the required intracardiac echocardiography catheter is available and obtained without a qualifying procurement or supply-chain disruption. This cohort serves as the observational comparison group for evaluating time to procedure, rescheduling, device substitution, procurement burden, and other predefined healthcare-delivery outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing or scheduled for electrophysiology, cardiac ablation, structural heart, or related cardiovascular procedures in which an intracardiac echocardiography catheter is clinically relevant. Participants will be classified according to whether the associated ICE catheter procurement episode involves a documented access disruption or timely device availability. The population may include individuals associated with procurement events involving original-manufacturer or legally reprocessed ICE catheter products. Clinical treatment decisions remain independent of study participation.
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Participant is scheduled for, referred for, or undergoing an electrophysiology, cardiac ablation, structural heart, or other cardiovascular procedure for which intracardiac echocardiography or an ICE catheter is clinically planned, requested, considered, or utilized.
- A documented ICE-catheter procurement or device-access episode can be identified and evaluated under the study protocol.
- Sufficient procurement, scheduling, clinical, or administrative information is available to determine device-access timing and study outcomes.
- Participant falls within either the documented ICE catheter access-disruption cohort or the timely-access comparison cohort.
Key exclusion criteria (7 listed)
- Younger than 18 years of age.
- No planned, requested, or clinically relevant intracardiac echocardiography catheter involvement in the associated cardiovascular procedure.
- Procurement or clinical records are insufficient to establish the timing or final disposition of the device-access episode.
- Device access occurred outside the predefined study observation period.
- Procedure delay or cancellation is clearly attributable solely to an unrelated clinical or administrative circumstance and no qualifying ICE catheter access event occurred.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracardiac Echocardiography CatheterAlso: ICE Catheter; Intracardiac Ultrasound Catheter; AcuNavA U.S. FDA-regulated intracardiac echocardiography catheter used to provide real-time intracardiac ultrasound imaging during electrophysiology, cardiac ablation, structural heart, and related cardiovascular procedures. The study does not assign participants to a particular catheter or alter clinical treatment. Instead, it prospectively observes access to the device, including availability, procurement, fulfillment, substitution, and supply-chain disruption, and evaluates associated effects on procedural access and healthcare delivery. | Device | ICE Catheter Access Disruption Cohort, Timely ICE Catheter Access Cohort |
Primary outcome
Time to Successful ICE Catheter Procurement
Time frame: From initial procurement request through device fulfillment, up to 90 days
Number of calendar days from the initial documented request for an intracardiac echocardiography catheter to confirmed procurement or fulfillment of the requested device. The measure will be compared between participants associated with a documented device-access disruption and participants with timely device access.
Incidence of ICE Catheter Supply-Chain Disruption
Time frame: From initial procurement request through final procurement disposition, up to 90 days
Proportion of observed procurement episodes experiencing at least one predefined supply-chain disruption, including order rejection, cancellation, backorder, allocation, distributor restriction, shipment delay, non-fulfillment, or required substitution of the requested ICE catheter.
Procedure Delay Associated With ICE Catheter Access
Time frame: From planned procedure scheduling through completion of the procedure, up to 90 days
Number and proportion of participants whose planned cardiovascular or electrophysiology procedure is delayed, rescheduled, or otherwise deferred following a documented disruption in access to the required intracardiac echocardiography catheter.
8 secondary outcomes
Time From Planned to Actual Procedure
Time frame: Up to 90 days
Rate of Procedure Rescheduling or Cancellation
Time frame: Up to 90 days from the originally scheduled procedure date
ICE Catheter Device Substitution Rate
Time frame: From initial procurement request through procedure completion, up to 90 days
Number of Procurement Attempts Required for Successful Device Access
Time frame: From initial procurement request through final disposition, up to 90 days
ICE Catheter Order Non-Fulfillment Rate
Time frame: Up to 90 days following each procurement request
Procurement Administrative Burden
Time frame: From initial procurement request through final disposition, up to 90 days
Mean Difference Between Initially Quoted and Final ICE Catheter Acquisition Cost
Time frame: From initial quotation through final acquisition, up to 90 days
Time to Alternative Device Sourcing
Time frame: Up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 18986404Dravid SG, Hope B, McKinnie JJ. Intracardiac echocardiography in electrophysiology: a review of current applications in practice. Echocardiography. 2008 Nov;25(10):1172-5. doi: 10.1111/j.1540-8175.2008.00784.x.
- Background: PubMed 32743700Isath A, Padmanabhan D, Haider SW, Siroky G, Perimbeti S, Correa A, Chahal CAA, Shenthar J, Asirvatham S, Mehta D. Does the use of intracardiac echocardiography during atrial fibrillation catheter ablation improve outcomes and cost? A nationwide 14-year analysis from 2001 to 2014. J Interv Card Electrophysiol. 2021 Sep;61(3):461-468. doi: 10.1007/s10840-020-00844-5. Epub 2020 Aug 2.
- Background: PubMed 29784681Enriquez A, Saenz LC, Rosso R, Silvestry FE, Callans D, Marchlinski FE, Garcia F. Use of Intracardiac Echocardiography in Interventional Cardiology: Working With the Anatomy Rather Than Fighting It. Circulation. 2018 May 22;137(21):2278-2294. doi: 10.1161/CIRCULATIONAHA.117.031343.
- Background: PubMed 35260997Alyesh D, Choe W, Demo H, Razminia M, Sundaram S. The Advanced Application of Intracardiac Echocardiography for Cardiac Electrophysiology Ablation Procedures. Curr Cardiol Rep. 2022 May;24(5):505-511. doi: 10.1007/s11886-022-01672-x. Epub 2022 Mar 9.
- Background: PubMed 33990269Gianni C, Sanchez JE, Della Rocca DG, Al-Ahmad A, Horton RP, Di Biase L, Natale A. Intracardiac Echocardiography to Guide Catheter Ablation of Atrial Fibrillation. Card Electrophysiol Clin. 2021 Jun;13(2):303-311. doi: 10.1016/j.ccep.2021.03.009. Epub 2021 Apr 23.
- FDA 510(k) - Medline ReNewal Reprocessed ACUSON AcuNav 10F Ultrasound CatheterLink provided by the sponsor.
- Siemens Healthineers - ACUNAV Intracardiac Echocardiography CathetersLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study may incorporate confidential clinical, procurement, contractual, commercial, and supply-chain information. Aggregate or appropriately de-identified findings may be reported in publications, regulatory communications, or research summaries consistent with applicable privacy requirements, IRB authorization, and data-use restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gavin C Solomon, MD principal investigator
Truway Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Arrhythmias, Cardiac, run by Truway Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful ICE Catheter Procurement (time frame: From initial procurement request through device fulfillment, up to 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788040, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.