Sphere-9 Catheter for VT
(Sphere-9 VT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have experienced ventricular tachycardia despite being on certain antiarrhythmic drugs, which suggests you may continue your current medication.
Is the Sphere-9 Catheter safe for use in humans?
What is the purpose of this trial?
Sphere-9 VT is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia due to prior myocardial infarction will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
Research Team
Vivek Reddy, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
This trial is for adults aged 18-85 who've had a heart attack before and now suffer from a type of irregular heartbeat called ventricular tachycardia, which hasn't improved with certain medications or devices designed to control heart rhythm. Participants must have experienced at least one episode in the past six months and be willing to follow the study's procedures.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are treated with the Sphere-9 Catheter and Affera Ablation System for ventricular tachycardia
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Sphere-9 Catheter with the Affera Mapping and Ablation System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medtronic Cardiac Rhythm and Heart Failure
Lead Sponsor
Geoff Martha
Medtronic Cardiac Rhythm and Heart Failure
Chief Executive Officer since 2020
MBA from University of Minnesota
Dr. Kweli Thompson
Medtronic Cardiac Rhythm and Heart Failure
Chief Medical Officer since 2022
MD from Harvard Medical School
Medtronic Cardiac Ablation Solutions
Lead Sponsor