Sinus Node DysfunctionNCT03903107
The Fluoroless-CSP Trial Using Electroanatomic Mapping
A study testing Conventional fluoroscopy guided Conduction System Pacing(CSP) and Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP) in people with Sinus Node Dysfunction and Heart Block AV, run by Rush University Medical Center at 1 site in United States.
Trial summary
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Dysfunction, Heart Block AV, LBBB
- What is being tested?
- Conventional fluoroscopy guided Conduction System Pacing(CSP) and Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age > 18 years
- Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device
Who cannot join
- Existing cardiac device including Pacemaker or Cardiac Resynchronization Therapy device
- Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- Pregnancy
- Difficulty with follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Fluoroless Conduction System Pacing Utilizing Electro-Anatomic Mapping Versus Conventional Implantation: The Fluoroless- CSP Trial
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.
Read the detailed description
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.
In this study, we plan to randomize patients to fluoroscopy guided CSP vs 3D mapping guided CSP implants with low/zero fluoroscopy. The study with assess if 3D EAM guided implants can be performed successfully and without any significant increase in device implant related complications.
- Conditions
- Sinus Node Dysfunction, Heart Block AV, LBBB, Heart Failure, Systolic
- Being tested
- Conventional fluoroscopy guided Conduction System Pacing(CSP), Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)
- Medical subject headings
- Sick Sinus Syndrome, Atrioventricular Block, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional fluoroscopy guided Conduction System Pacing(CSP)Procedure or surgery
conventional standard approach Conduction System Pacing(CSP) using fluoroscopy
Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)Procedure or surgery
Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| Conventional Conduction System Pacing(CSP) using fluoroscopy | Placebo comparator | Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique. Receives: Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP) |
| Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system | Experimental | Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure. Receives: Procedure: Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of achieving CSP
Feasibility of achieving a successful CSP implant at the His Bundle or Left Bundle branch with low or zero Fluoroscopy. This will result in low to no fluoroscopy exposure for both the subject and the operator, as well as shorter procedure times.This will be documented during procedure.
Measured: Intra-procedure
Secondary outcomes (3)
Total radiation exposure time during procedure
Total radiation exposure during procedure time will be documented at the total time the patient is exposed to fluoroscopy during the procedure. This will will be tracked and documented as total fluoroscopy duration, His lead Fluoroscopy duration and DAP. The total amounts of procedural fluoroscopy exposure will be compared between the two treatment arms.
Measured: Intra-procedure
Procedure-related complications
The study team will review medical history of enrolled subjects for any adverse event experienced post-procedurally. All adverse events will be reviewed by PI for determination as to whether "procedure-related" or not.
Measured: 30 days post procedure
Need for His Lead revisions
The study team will track the device follow-up data for a duration of 3 months post device implant. Any patients with > 2V increase in His Lead capture threshold from baseline and need for ventricular pacing will undergo a lead revision.
Measured: for a period of 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start26 Oct 2020
- Primary completion1 Apr 2021
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinus Node DysfunctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CSP can be achieved successfully and safely utilizing electro-anatomic mapping (EAM) with the CARTO 3mapping system
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903107
- Sponsor's protocol ID
- 18090701
- Status last verified
- Feb 2025
- First submitted
- 31 Oct 2018
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma PS, Huang HD, Trohman RG, Naperkowski A, Ellenbogen KA, Vijayaraman P. Low Fluoroscopy Permanent His Bundle Pacing Using Electroanatomic Mapping: A Feasibility Study. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006967. doi: 10.1161/CIRCEP.118.006967.
PubMed 30704289
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroless Conduction System Pacing Utilizing Electro-Anatomic Mapping Versus Conventional Implantation: The Fluoroless- CSP Trial
- ClinicalTrials.gov ID
- NCT03903107
- Acronym / sponsor ID
- 18090701
- Conditions
- Sinus Node Dysfunction, Heart Block AV, LBBB, Heart Failure, Systolic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 4 Apr 2019 (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 goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.
Detailed description
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.
In this study, we plan to randomize patients to fluoroscopy guided CSP vs 3D mapping guided CSP implants with low/zero fluoroscopy. The study with assess if 3D EAM guided implants can be performed successfully and without any significant increase in device implant related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- CSP can be achieved successfully and safely utilizing electro-anatomic mapping (EAM) with the CARTO 3mapping system
| Arm | Type | Receives |
|---|---|---|
| Conventional Conduction System Pacing(CSP) using fluoroscopy | Placebo comparator | Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP)Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique. |
| Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system | Experimental | Procedure: Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device
Key exclusion criteria (4 listed)
- Existing cardiac device including Pacemaker or Cardiac Resynchronization Therapy device
- Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
- Pregnancy
- Difficulty with follow-up
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 |
|---|---|---|
| Conventional fluoroscopy guided Conduction System Pacing(CSP)conventional standard approach Conduction System Pacing(CSP) using fluoroscopy | Procedure or surgery | Conventional Conduction System Pacing(CSP) using fluoroscopy |
| Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy | Procedure or surgery | Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system |
Primary outcome
Success of achieving CSP
Time frame: Intra-procedure
Feasibility of achieving a successful CSP implant at the His Bundle or Left Bundle branch with low or zero Fluoroscopy. This will result in low to no fluoroscopy exposure for both the subject and the operator, as well as shorter procedure times.This will be documented during procedure.
3 secondary outcomes
Total radiation exposure time during procedure
Time frame: Intra-procedure
Procedure-related complications
Time frame: 30 days post procedure
Need for His Lead revisions
Time frame: for a period of 6 months post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Results publication: PubMed 30704289Sharma PS, Huang HD, Trohman RG, Naperkowski A, Ellenbogen KA, Vijayaraman P. Low Fluoroscopy Permanent His Bundle Pacing Using Electroanatomic Mapping: A Feasibility Study. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006967. doi: 10.1161/CIRCEP.118.006967.
- Individual participant dataSharing planned: No
Related trials for Sinus Node Dysfunction
RecruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
Recruiting
Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
Pacing Therapy, Cardiac Pacing
Recruiting
Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction
Bradycardia
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
RecruitingObservational study
BIO|STREAM.CSP CLS
Sinus Node Disease, Atrioventricular Block
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional fluoroscopy guided Conduction System Pacing(CSP) and Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP) in people with Sinus Node Dysfunction and Heart Block AV, run by Rush University Medical Center 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 28 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success of achieving CSP (time frame: Intra-procedure). 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 NCT03903107, which also lists 1 linked publication.
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 28 Feb 2025.