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 Winston-Salem, North Carolina.

Sponsor
Medtronic Cardiac Ablation Solutions
Study ID
NCT07585968
Status
Recruiting
Apply to this trial

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
Aug 17, 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 (3)

FacilityCityStateZIPSite coordinators
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-0001
Keishia Rodriguez
[email protected]
(336) 718-5807
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 Winston-Salem, NC

By research site
Atrium Health Wake Forest Baptist Medical Center· Winston-Salem, NCThe Ohio State University Wexner Medical Center· Columbus, OHTexas Cardiac Arrhythmia Research Foundation· Austin, TX

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