Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
Medtronic Cardiac Ablation Solutions
Summary
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Any of the following: 1. Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI). 2. Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging. 2. At least one episode of sustained (continuous for \>30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment. 3. Recurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or ICD int…
Interventions
- DeviceSphere-9 Catheter with the Affera Mapping and Ablation System
Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.
Locations (6)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Icahn School of Medicine at Mount SinaiNew York, New York
- Cleveland Clinic FoundationCleveland, Ohio
- Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania
- Vanderbilt University Medical CenterNashville, Tennessee
- Texas Cardiac Arrhythmia Research FoundationAustin, Texas