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NCT03490201 · ClinicalTrials.gov registry record · NA
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
A NA study of Ventricular Tachycardia, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 592
- Enrollment target
- 20
- Study locations
NCT03490201: Completed NA study of Ventricular Tachycardia, sponsored by Abbott Medical Devices.
NCT03490201 is a NA study of Ventricular Tachycardia that has completed, run by Abbott Medical Devices. The registered enrollment target is 592 participants, above the 268-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (121% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03490201, a NA study of Ventricular Tachycardia, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 592 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.
Primary Outcome
The primary safety endpoint is a composite of cardiovascular-related and procedure-related major complications through 7 days post index ablation procedure.
Conditions Studied
Interventions
- DEVICE FlexAbility SE Ablation Catheter
- DEVICE Market Approved RF Ablation System
Study Locations (20)
California
- USC University Hospital - Los Angeles
- Ronald Reagan UCLA Medical Center - Los Angeles
- University of California at San Diego (UCSD) Medical Center - San Diego
Florida
- Broward General Medical Center - Fort Lauderdale
- Memorial Regional Hospital - Hollywood
- University of South Florida - Tampa
Alabama
- Affinity Cardiovascular Specialists, LLC - Birmingham
- University Hospital - Univ. of Alabama at Birmingham (UAB) - Birmingham
Minnesota
- VA Medical Center Minneapolis - Minneapolis
- Mayo Clinic - Rochester
Colorado
- University of Colorado Hospital - Aurora
Georgia
- Emory University Hospital - Atlanta
Illinois
- University of Chicago - Chicago
Maryland
- Johns Hopkins University Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 592 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2024-04-11 |
| Phase | NA |
What the finished NCT03490201 record still lists
NCT03490201 is an interventional study that assigns participants to a tested intervention. The registered 592 participants enrollment target is mid-sized for trials with a published cap, above the 268-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (121% higher).
The record links to 1 condition, with Ventricular Tachycardia appearing as the primary indexed condition, and to 2 interventions - of which FlexAbility SE Ablation Catheter is the first listed.
NCT03490201 names 20 study sites across 14 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT03490201 about?
NCT03490201 is a clinical study titled "FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study". This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmi...
What is the current status of trial NCT03490201?
This trial is currently completed. It is a NA study. The enrollment target is 592 participants. The study started on 2018-06-01. Estimated completion is 2024-04-11.
What conditions does trial NCT03490201 study?
This clinical trial studies the following conditions: Ventricular Tachycardia.
What interventions are being tested in trial NCT03490201?
The interventions under investigation include: FlexAbility SE Ablation Catheter (DEVICE), Market Approved RF Ablation System (DEVICE).
Who is sponsoring clinical trial NCT03490201?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03490201 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ventricular Tachycardia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03490201's enrollment target sits among peer trials
592 4th of 28 higher than 25 of 28 other Ventricular Tachycardia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ventricular Tachycardia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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