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COMPLETED NA

FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study

NCT03490201 · View on ClinicalTrials.gov ↗

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

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

155 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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 592 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03490201 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03490201?

The interventions under investigation include: FlexAbility SE Ablation Catheter (DEVICE), Market Approved RF Ablation System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03490201?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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