RecruitingVentricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Eligible age
18–85 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: Medtronic Cardiac Ablation Solutions
You may qualify if…
- ✓ 1. Prior myocardial infarction (MI).
- ✓ 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 2 months prior to the ablation procedure.
- ✓ 5. Age 18 through 85 years old.
- ✓ 6. Willing and able to provide informed consent.
- ✓ 7. Willing and able to comply with all pre-, post-, and follow-up testing requirements.
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. Idiopathic VT or VT of non-ischemic cardiomyopathy.
- ✕ 4. VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia).
- ✕ 5. VT or VF thought to be from channelopathies.
- ✕ 6. 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.
- ✕ 7. Sarcoidosis.
- ✕ 8. Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07585968 · last updated 2026-10-26