Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) (NCT06703489)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (40 items).
Location: Beth Israel Deaconess Medical Center — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- Lamin or titin genetic mutation
- 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.
- VT or VF thought to be from channelopathies.
- More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation within 4 weeks prior to the ablation procedure.
- Sarcoidosis.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Icahn School of Medicine at Mount Sinai — New York, New York
- Cleveland Clinic Foundation — Cleveland, Ohio
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
- Vanderbilt University Medical Center — Nashville, Tennessee
- Texas Cardiac Arrhythmia Research Foundation — Austin, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.