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-9™ Catheter and Affera™ 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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.