NCT02130765

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

Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 50 centers in the United States (US) will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months.

Conditions

• Monomorphic Ventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	Cardiac catheter ablation with ICD/CRT-D	Cardiac ablation catheter system

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-07-25
• Completion: 2016-07-25
• First posted: 2014-05-05
• Last updated: 2019-02-12
• Results posted: 2018-10-15

Locations

38 sites across 5 countries: United States, Australia, France, Italy, United Kingdom

Regulatory

• FDA-regulated device study