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

NCT03490201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2025-01-08

No results posted yet for this 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

  • Ventricular Tachycardia

Interventions

DEVICE

Market Approved RF Ablation System

Subjects receive ablation using an FDA approved radiofrequency (RF) ablation system.

DEVICE

FlexAbility SE Ablation Catheter

Subjects receive ablation treatment using an ablation system that is not FDA approved.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Sarah Kammer · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2024-04-11
Completion
2024-04-11
FDA Device
Yes

Countries

  • United States
  • Australia
  • Czechia
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03490201 on ClinicalTrials.gov