Sphere-9 Catheter for VT

(Sphere-9 VT Trial)

Recruiting at 3 trial locations

Overseen By Josh Treadway

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Must be taking: Antiarrhythmics

Disqualifiers: Heart failure, Renal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

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?

The available research does not provide specific safety data for the Sphere-9 Catheter, but it highlights the importance of monitoring and reporting adverse effects in similar catheter ablation procedures to ensure patient safety. ^{1 2 3 4 5}

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

I am willing and able to follow all testing requirements.

I have had a fast heart rate that didn't stop despite taking specific heart medications or having a device implanted.

I am willing and able to agree to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the Sphere-9 Catheter and Affera Ablation System for ventricular tachycardia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

Treatment Details

Interventions

• Sphere-9 Catheter with the Affera Mapping and Ablation System

Trial Overview The Sphere-9 VT study is testing how safe and effective the Sphere-9 Catheter combined with the Affera Ablation System is in treating recurrent ventricular tachycardia that occurs after a previous heart attack. This non-randomized trial will enroll participants to undergo this specific treatment without comparing it to other treatments.

Participant Groups

Group I: Ventricular tachycardia catheter ablation Experimental Treatment 1 Intervention

Ablation using the Sphere-9 Catheter with the Affera Mapping and Ablation System

Who Is Running the Clinical Trial?

Medtronic Cardiac Rhythm and Heart Failure

Lead Sponsor

Trials

206

Recruited

137,000+

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

Trials

29

Recruited

16,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Global multielectrode contact-mapping plus ablation with a single catheter in patients with atrial fibrillation: Global AF study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Initial clinical experience of atrial fibrillation ablation guided by a cryoballoon-compatible, magnetic-based circular catheter. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Circular mapping catheter entrapment in the mitral valve apparatus: a previously unrecognized complication of focal atrial fibrillation ablation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

PV Isolation Using a Spherical Array PFA Catheter: Preclinical Assessment and Comparison to Radiofrequency Ablation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Safety of Catheter Ablation for Atrial Fibrillation in Patients With Prior Cerebrovascular Events. [2021]