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Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia

NCT02130765 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2019-02-12

Study results available
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Summary

To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia \[MMVT\] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.

Conditions

  • Monomorphic Ventricular Tachycardia

Interventions

DEVICE

Cardiac catheter ablation with ICD/CRT-D

Cardiac ablation catheter system

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

  • Francis Marchlinski, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-07-25
Completion
2016-07-25
FDA Device
Yes

Countries

  • United States
  • Australia
  • France
  • Italy
  • 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 NCT02130765 on ClinicalTrials.gov