Cardiac ArrhythmiasViewFlex X FIHNCT06772493
ViewFlex X ICE First-in-Human Study
An observational study of Cardiac Arrhythmias, run by Abbott Medical Devices at 8 sites in United States.
Trial summary
This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- ViewFlex X ICE System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Dec 2024to Jun 2026
- 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: This clinical investigation will enroll subjects of all genders over the age of 18 undergoing any previously planned electrophysiology study procedure utilizing ICE.
Who may be able to join
- A patient will be eligible for clinical trial participation if they meet the following criteria:
- Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
- Plans to undergo any EP procedure utilizing ICE
- At least 18 years of age
Who cannot join
- A patient will be excluded from enrollment in the study if they meet any of the following criteria:
- Subject is currently participating in another clinical trial with an active treatment arm or has participated in such a clinical trial within 30 days prior to enrollment that may interfere with this clinical trial without pre-approval from this study Sponsor
- Implanted mechanical mitral or tricuspid valve replacement
- Implanted intracardiac device within 30 days
- Pregnant or nursing
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amber Miller, PhD contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Krista Szymanski, 843-876-6846, szymanski@musc.edu
Jeffrey Winterfield, MD
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Chinwe Ngumezi, 346-238--290, ccngumezi@houstonmethodist.org
Amish Dave, MD
- Recruiting
Ascension St. Vincent's Riverside
Jacksonville, Florida, 32204
- Recruiting
St. Bernards Medical Center
Jonesboro, Arkansas, 72401
Kayla Rubino, 870-935-6729, krubino@dnairresearch.com
Devi Nair, MD
- Recruiting
Research Medical Center
Kansas City, Missouri, 64132
Donita Atkins, (913) 934-4300, Donita.Atkins@HCAHealthcare.com
Rakesh Gopinathannair, MD
- Recruiting
University of California, San Diego
La Jolla, California, 92037
Jesus Gil, 858-246-2405, jegil@health.ucsd.edu
Jonathan Hsu, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
April Jacob, 212-263-7704, april.jacob@nyulangone.org
Larry Chinitz, MD
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mary Gnap, 215-349-8446, mary.gnap@pennmedicine.upenn.edu
Fermin Garcia, MD
About this study
This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).
- Conditions
- Cardiac Arrhythmias
- Being tested
- ViewFlex X ICE System
- Keywords
- Intracardiac Echocardiography, cardiac electrophysiology
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViewFlex X ICE SystemDevice
Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System Receives: Device: ViewFlex X ICE System | |
| Cohort 2 | Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System Receives: Device: ViewFlex X ICE System | |
| Cohort 3 | Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System Receives: Device: ViewFlex X ICE System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures.
Measured: During the procedure
Physician assessment of the ability to use anatomic ICE markers and ICE geometry as a reference during mapping and ablation procedures.
Measured: during the procedure
Rate of device- or procedure-related serious adverse events that occur through patient discharge.
Measured: during the procedure and periprocedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start16 Dec 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristin Ruffner, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772493
- Sponsor's protocol ID
- ABT-CIP-10528
- Acronym
- ViewFlex X FIH
- Status last verified
- May 2026
- First submitted
- 2 Jan 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ViewFlex X ICE First-in-Human Study
- ClinicalTrials.gov ID
- NCT06772493
- Acronym / sponsor ID
- ViewFlex X FIH / ABT-CIP-10528
- Conditions
- Cardiac Arrhythmias
- Keywords
- Intracardiac Echocardiography, cardiac electrophysiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Jan 2025 (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.
This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: ViewFlex X ICE SystemSingle Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System |
| Cohort 2 | – | Device: ViewFlex X ICE SystemSingle Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System |
| Cohort 3 | – | Device: ViewFlex X ICE SystemSingle Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical investigation will enroll subjects of all genders over the age of 18 undergoing any previously planned electrophysiology study procedure utilizing ICE.
Key inclusion criteria (4 listed)
- A patient will be eligible for clinical trial participation if they meet the following criteria:
- Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
- Plans to undergo any EP procedure utilizing ICE
- At least 18 years of age
Key exclusion criteria (6 listed)
- A patient will be excluded from enrollment in the study if they meet any of the following criteria:
- Subject is currently participating in another clinical trial with an active treatment arm or has participated in such a clinical trial within 30 days prior to enrollment that may interfere with this clinical trial without pre-approval from this study Sponsor
- Implanted mechanical mitral or tricuspid valve replacement
- Implanted intracardiac device within 30 days
- Pregnant or nursing
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 |
|---|---|---|
| ViewFlex X ICE SystemSubjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System | Device | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures.
Time frame: During the procedure
Physician assessment of the ability to use anatomic ICE markers and ICE geometry as a reference during mapping and ablation procedures.
Time frame: during the procedure
Rate of device- or procedure-related serious adverse events that occur through patient discharge.
Time frame: during the procedure and periprocedurally
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 2 Jun 2026.
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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.
Amber Miller, PhD contact
Kristin Ruffner, PhD study director
Abbott
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by Abbott Medical Devices at 8 sites 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Contact Ben Gansemer, PhD (9527152719, benjamin.gansemer@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures. (time frame: During the procedure). 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?
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 2 Jun 2026.