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Sphere-9 VT EFS Study for Ventricular Tachycardia

This study is testing the safety and effectiveness of a new treatment for Ventricular Tachycardia (VT), a fast and irregular heartbeat. The treatment uses the Sphere-9 Catheter with the Affera Mapping and Ablation System. You may be able to join if you are an adult between 18 and 85 years old, have recurrent VT, and have scar tissue in your heart from a heart attack or other heart condition. Researchers will look at how safe the procedure is within 7 days and if it successfully treats your VT on the day of the procedure. The study is currently enrolling 60 participants.

Study design
This is a feasibility study involving 60 adult participants. It is a multi-center, non-randomized, and unblinded study.
What's involved
You would undergo an ablation procedure using the Sphere-9 Catheter with the Affera Mapping and Ablation System. Your safety will be assessed within 7 days after the procedure, and effectiveness on the day of the procedure.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be checked for up to 7 days after the procedure. The effectiveness of the procedure will be assessed on the day it is performed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06703489

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

Recruiting
NAAges 18–85InterventionalTreatment
Medtronic Cardiac Ablation Solutions
~60 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Sphere-9 Catheter with the Affera Mapping and Ablation System

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint: evaluate the safety of the index ablation procedure
Measured over Within 7 days post-procedure
+1 more outcome measured

Conditions

Ventricular Tachycardia (VT)

Explore related trials

Generalized ischemic myocardial dysfunctionVentricular Tachycardia

Where it's being run

6 sites across 6 states
Massachusetts1
New York1
Ohio1
Pennsylvania1
Tennessee1
Texas1

Study leadership

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

Who to contact

Josh Treadway
[email protected]
817-412-0608
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Primary Safety Endpoint: evaluate the safety of the index ablation procedureWithin 7 days post-procedure

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

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

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