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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Medtronic Cardiac Ablation Solutions
Study ID
NCT07585968
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Ventricular Tachycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
May 14, 2026
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
260 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ventricular tachycardia catheter ablation
    Ablation using the Sphere-9 Catheter with the Affera Mapping and Ablation System

Primary Outcome Measure

Primary Safety [ Time Frame: As applicable, within 7 days or 3 months after the index ablation procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43210-1240
Adrianne Miller
[email protected]
(614) 688-8252
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705-1852
Deb Cardinal
[email protected]
(512) 522-9410

Find similar trials in Columbus, OH

By research site
The Ohio State University Wexner Medical Center· Columbus, OHTexas Cardiac Arrhythmia Research Foundation· Austin, TX

Related Studies