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

NCT07585968 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

DEVICE

Sphere-9 Catheter with the Affera Mapping and Ablation System

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

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Vivek Reddy, MD · Icahn School of Medicine at Mount Sinai

  • Pasquale Santangeli, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-03-31
Completion
2028-09-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585968 on ClinicalTrials.gov