NCT03490201

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

FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a regulated, prospective, multi-center trial designed to evaluate the safety and effectiveness of the FlexAbility\[TM\] Ablation Catheter, Sensor Enabled\[TM\] (FlexAbility SE) catheter to obtain an indication to treat monomorphic ventricular tachycardia (MMVT) in the United States of America (US). The clinical trial has two cohorts: one is a randomized ischemic cardiomyopathy (ICM) cohort and the second is a concurrent single-arm non-ischemic cardiomyopathy (NICM) cohort. Four hundred ten (410) subjects with drug refractory sustained MMVT and ICM and 182 subjects with drug refractory sustained MMVT and NICM will be enrolled at up to 35 centers worldwide. Study subjects who have drug refractory sustained MMVT and ICM will be randomized 1:1 to treatment with the FlexAbility SE catheter ablation system in the Treatment group, or the ThermoCool, ThermoCool NaviStar, or ThermoCool SmartTouch Ablation Catheter from Biosense Webster in the Control group. Since at study start there was no approved device for VT ablation in patients with NICM to use as a comparator, subjects who have drug refractory MMVT and NICM will be treated with the FlexAbility SE catheter ablation system only.

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-01
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2018-04-06
• Last updated: 2025-01-08

Locations

32 sites across 8 countries: United States, Australia, Czechia, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated device study