RecruitingVentricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Eligible age
18–85 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: Medtronic Cardiac Ablation Solutions
You may qualify if…
- ✓ 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 intervention.
- ✓ 4. Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 3 months prior to the ablation procedure.
- ✓ 5. Age 18 through 85 years old.
- ✓ 6. Willing and able to provide informed consent.
You may not qualify if…
- ✕ 1. Incessant VT necessitating hemodynamic support prior to the ablation procedure.
- ✕ 2. Unstable polymorphic VT or ventricular fibrillation (VF).
- ✕ 3. VTs due to any of the following:
- ✕ 1. Idiopathic VT
- ✕ 2. Automaticity or triggered activity
- ✕ 3. Lamin or titin genetic mutation
- ✕ 4. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).
- ✕ 4. NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.
Where it's recruiting
Massachusetts
Boston
New York
New York
Ohio
Cleveland
Pennsylvania
Philadelphia
Tennessee
Nashville
Texas
Austin
Source: ClinicalTrials.gov · NCT06703489 · last updated 2026-09-03