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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Medtronic Cardiac Ablation Solutions
Study ID
NCT06703489
Status
Recruiting
Apply to this trial

Conditions

  • Ventricular Tachycardia (VT)

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 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.

Study Details

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 Dates

Start date
Mar 18, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
60 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 Endpoint: evaluate the safety of the index ablation procedure [ Time Frame: Within 7 days post-procedure ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jenifer Kaufman
[email protected]
(617) 632-8956
Andre d'Avila, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Betsy Ellsworth
[email protected]
(212) 241-6500
Srinivas Dukkipati, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Jill Kandrac
[email protected]
(216) 444-2521
Pasquale Santangeli, MD (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Mary Gnap
[email protected]
(215) 349-8446
Francis Marchlinski, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Terry Weyand
[email protected]
615-322-9349
William Stevenson, MD (PRINCIPAL_INVESTIGATOR)
Texas Cardiac Arrhythmia Research FoundationAustinTexas78705
Deb Cardinal
[email protected]
512-522-9410
David Burkhardt, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MAIcahn School of Medicine at Mount Sinai· New York, NYCleveland Clinic Foundation· Cleveland, OHHospital of the University of Pennsylvania· Philadelphia, PAVanderbilt University Medical Center· Nashville, TNTexas Cardiac Arrhythmia Research Foundation· Austin, TX

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