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

NCT07585968 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Sphere VT
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ventricular Tachycardia

Keywords

Recurrent sustained scar-related monomorphic ventricular tachycardia; Ventricular tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Ischemic heart disease; Patient with Implantable Cardioverter Defibrillator (ICD); Ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Primary Safety

  A pre-defined list of device- or procedure-related SAEs, as adjudicated by the Clinical Events Committee (CEC), occurring within 7 days after the index ablation procedure (or within 3 months after the index ablation procedure for any esophago-pericardial fistula/esophageal perforation) will be considered a primary safety event.

  As applicable, within 7 days or 3 months after the index ablation procedure

• Primary Effectiveness

  Freedom from recurrence of sustained monomorphic VT (MMVT) in the absence of new or increased dose of Class I or III antiarrhythmic drugs (AAD) through 6 months after the index ablation procedure.

  Through 6 months after the index ablation procedure

Study Arms (1)

Ventricular tachycardia catheter ablation

EXPERIMENTAL

Ablation using the Sphere-9 Catheter with the Affera Mapping and Ablation System

Device: Sphere-9 Catheter with the Affera Mapping and Ablation System

Interventions

Sphere-9 Catheter with the Affera Mapping and Ablation System DEVICE

Adult subjects with ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.

Ventricular tachycardia catheter ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Unstable angina.
• Active myocardial ischemia.
• Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
• Any percutaneous coronary intervention performed in a setting of unstable angina or acute MI (STEMI or non-STEMI) within 2 months (60 days) prior to the ablation procedure. Note: elective PCI performed during elective angiogram would be excluded only if occurring within 30 days prior to the ablation procedure.
• Left ventricular ejection fraction (LVEF) \<15%.
• NYHA Class IV heart failure.
• Decompensated heart failure.

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

MeSH Terms

Conditions

Tachycardia, Ventricular; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Tachycardia; Cardiac Conduction System Disease; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Pasquale Santangeli, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josh Treadway

CONTACT

817-412-0608; josh.b.treadway@medtronic.com

Analyn Jackson

CONTACT

214-697-9894; analyn.u.jackson@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share