Sphere-9 Catheter for VT

(Sphere-9 VT Trial)

Recruiting at 4 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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with ventricular tachycardia (VT), a heart condition that causes dangerously fast heartbeats, especially after a prior heart attack. The treatment uses the Sphere-9 Catheter with the Affera Mapping and Ablation System to determine its effectiveness in stopping VT episodes. Ideal participants have experienced repeat VT episodes despite having a defibrillator or taking medication and have had a heart attack in the past. The trial aims to explore the feasibility of this new approach in managing VT. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to innovative VT treatments.

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.

What prior data suggests that the Sphere-9 Catheter with the Affera Mapping and Ablation System is safe for treating ventricular tachycardia?

Research has shown that the Sphere-9 Catheter with the Affera Mapping and Ablation System has produced positive results in early studies. These studies focused on patients with ventricular tachycardia, a type of fast heartbeat. The results suggest that the system is generally well-tolerated.

Researchers did not find major safety concerns in these studies. However, detailed information on side effects remains limited at this stage. The treatment is still in the early testing phase, so researchers are primarily assessing the system's safety and effectiveness.

So far, no reports of serious side effects have emerged, which is encouraging. However, like any medical treatment, some risk exists. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Sphere-9 Catheter with the Affera Mapping and Ablation System is unique because it potentially offers a more precise approach to treating ventricular tachycardia (VT). Unlike current standard treatments like radiofrequency ablation, which might not always accurately target the problematic heart tissue, this system integrates mapping and ablation into one catheter, enhancing precision. Researchers are excited because this could lead to more effective procedures with fewer complications, ultimately improving patient outcomes in managing VT.

What evidence suggests that the Sphere-9 Catheter is effective for ventricular tachycardia?

Studies have shown that the Sphere-9 Catheter with the Affera Mapping and Ablation System, which participants in this trial will receive, effectively treats ventricular tachycardia, a fast and irregular heartbeat. Early results suggest that this system, with its unique "large-footprint" design, creates larger treated areas in the heart, improving the targeting of problem spots. This method has successfully treated patients with heart issues from previous heart attacks. Research indicates that this catheter could enhance treatment outcomes by making the procedure more efficient and potentially more effective. ^{1 2 3 4 5}

Who Is on the Research Team?

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. news.medtronic.com news.medtronic.com/Medtronic-announces-positive-results-from-early-feasibility-study-of-the-Sphere-9-TM-Catheter-with-Affera-TM-Mapping-and-Ablation-System-for-treatment-of-ventricular-tachycardia

Medtronic announces positive results from early feasibility ... Medtronic announces positive results from early feasibility study of the Sphere-9™ Catheter with Affera™ Mapping and Ablation System for ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06703489?term=NCT06703489&rank=1

Study Details | NCT06703489 | Safety and Performance ... Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, monomorphic ventricular ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11577951/

Mapping and ablation of ventricular tachycardia using dual ... We investigated procedural and clinical outcomes of VT ablation using a novel 'large-footprint' catheter that allows the creation of larger lesions.

4. academic.oup.com academic.oup.com/europace/article/27/9/euaf139/8182687

Safety and efficacy of a lattice-tip catheter for ventricular ... The prototype of this technology is the lattice-tip catheter (Sphere-9, AFFERA, Medtronic) that promises improved procedural efficacy. This catheter is a ...

5. heartrhythmcasereports.com heartrhythmcasereports.com/article/S2214-0271(25)00025-9/fulltext

De novo ventricular tachycardia ablation with stacked ... A lattice-tipped dual-energy mapping and ablation catheter can successfully be used in de novo procedures to map and ablate VT in ischemic cardiomyopathy.