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

NCT06703489 | Recruiting FDA Device

• 1 other identifier: Sphere-9 VT EFS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Ventricular Tachycardia (VT)

Keywords

Recurrent sustained monomorphic ventricular tachycardia; 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 Endpoint: evaluate the safety of the index ablation procedure

  Percentage of patients with device- or procedure-related cardiovascular- or pulmonary-related serious adverse events

  Within 7 days post-procedure

• Primary Effectiveness Endpoint: assess acute procedural success of the index ablation procedure

  Percentage of patients whose targeted clinically relevant monomorphic ventricular tachycardia cannot be induced

  Day of ablation procedure

Secondary Outcomes (1)

• Secondary Endpoint: assess chronic effectiveness of the index ablation procedure

  Within 6 months post-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 recurrent, sustained, scar-related monomorphic 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:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (6)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

NOT YET RECRUITING

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

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: November 21, 2024
• First Posted: November 25, 2024
• Study Start: March 18, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)