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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 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.

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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.

Conditions Studied

Ventricular Tachycardia

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

FieldValue
Enrollment Target 592 participants
Start Date 2018-06-01
Est. Completion 2024-04-11
Phase NA

Sponsor

Abbott Medical Devices

261 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03490201

The ClinicalTrials.gov registry entry for NCT03490201 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 592 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 268-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (121% higher). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.