Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the T… (NCT06703489) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Performance Assessment of the Sphere-9â„¢ Catheter and Afferaâ„¢ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
United States60 participantsStarted 2025-03-18
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Any of the following:
✓. Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI).
✓. Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging.
✓. 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.
✓. Recurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or ICD intervention.
✓. Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 3 months prior to the ablation procedure.
✓. Age 18 through 85 years old.
✓. Willing and able to provide informed consent.
Exclusion criteria
✕. Incessant VT necessitating hemodynamic support prior to the ablation procedure.
✕. Unstable polymorphic VT or ventricular fibrillation (VF).
✕. VTs due to any of the following:
✕. Idiopathic VT
✕. Automaticity or triggered activity
What they're measuring
1
Primary Safety Endpoint: evaluate the safety of the index ablation procedure
Timeframe: Within 7 days post-procedure
2
Primary Effectiveness Endpoint: assess acute procedural success of the index ablation procedure
✕. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).
✕. NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.