Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment … (NCT07585968) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
260 participantsStarted 2026-06
Plain-language summary
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) 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
. Prior myocardial infarction (MI).
. 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 2 months prior to the ablation procedure.
. Age 18 through 85 years old.
. Willing and able to provide informed consent.
. Willing and able to comply with all pre-, post-, and follow-up testing requirements.
Exclusion criteria
. Incessant VT necessitating hemodynamic support prior to the ablation procedure.
. Unstable polymorphic VT or ventricular fibrillation (VF).
. Idiopathic VT or VT of non-ischemic cardiomyopathy.
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
Timeframe: As applicable, within 7 days or 3 months after the index ablation procedure
2
Primary Effectiveness
Timeframe: Through 6 months after the index ablation procedure
. VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia).
. 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.
. Hypertrophic cardiomyopathy, except when due to an apical aneurysm.