Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)

Recruiting now · Not applicable

Conditions studied: Ventricular Tachycardia (VT)

In brief

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.

Key facts

Study ID

NCT06703489

Run by

Medtronic Cardiac Ablation Solutions

People needed

60

Starts

2025-03-18

Expected to finish

2027-01-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Willing and able to comply with all pre-, post-, and follow-up testing requirements.

You may not qualify if…

• 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.
• Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
• Unstable angina.
• Active myocardial ischemia.
• Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
• Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.
• Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
• Left ventricular ejection fraction (LVEF) <15%.
• NYHA Class IV heart failure.
• Decompensated heart failure.
• Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
• Ventricular assist device (VAD) implanted, planned or required for the procedure.
• Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.
• Presence of prosthetic valve in the aortic or mitral valve.
• Patients with advanced COPD (on home oxygen).

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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