Assessing a new catheter and ablation system for treating ventricular tachycardia

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

This study is testing a new catheter and ablation system to see if it can help adults with recurring ventricular tachycardia feel better after their heart problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Medtronic Cardiac Ablation Solutions (industry)
• Locations: 6 sites (Boston, Massachusetts and 5 other locations)
• Trial ID: NCT06703489 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and performance of the Sphere-9 Catheter and Affera Ablation System in adults with recurrent, sustained monomorphic ventricular tachycardia following a myocardial infarction. It is a prospective, multi-center, non-randomized, unblinded feasibility study that aims to enroll patients who have experienced episodes of ventricular tachycardia despite existing treatments. Participants will undergo treatment with the new catheter and ablation system to determine its effectiveness in managing their condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with a history of myocardial infarction and recurrent sustained monomorphic ventricular tachycardia.

Not a fit: Patients experiencing incessant ventricular tachycardia requiring hemodynamic support or those with unstable polymorphic ventricular tachycardia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from recurrent ventricular tachycardia, potentially improving their quality of life and reducing the risk of serious cardiac events.

How similar studies have performed: Other studies have shown promise in using catheter ablation for ventricular tachycardia, indicating that this approach is not entirely novel but may offer advancements in treatment.

Eligibility criteria

Inclusion Criteria:

1. Any of the following:

   1. Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI).
   2. Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging.
2. At least one episode of sustained (continuous for \>30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment.
3. Recurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or ICD intervention.
4. Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 3 months prior to the ablation procedure.
5. Age 18 through 85 years old.
6. Willing and able to provide informed consent.
7. Willing and able to comply with all pre-, post-, and follow-up testing requirements.

Exclusion Criteria:

1. Incessant VT necessitating hemodynamic support prior to the ablation procedure.
2. Unstable polymorphic VT or ventricular fibrillation (VF).
3. VTs due to any of the following:

   1. Idiopathic VT
   2. Automaticity or triggered activity
   3. Lamin or titin genetic mutation
   4. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).
4. NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.
5. VT or VF thought to be from channelopathies.
6. More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation within 4 weeks prior to the ablation procedure.
7. Sarcoidosis.
8. Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
9. Unstable angina.
10. Active myocardial ischemia.
11. Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
12. Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.
13. Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
14. Left ventricular ejection fraction (LVEF) \<15%.
15. NYHA Class IV heart failure.
16. Decompensated heart failure.
17. Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
18. Ventricular assist device (VAD) implanted, planned or required for the procedure.
19. Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.
20. Presence of prosthetic valve in the aortic or mitral valve.
21. Patients with advanced COPD (on home oxygen).
22. Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
23. Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
24. Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.
25. Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \<80,000).
26. Contraindication to anticoagulation.
27. End-stage renal disease (requiring dialysis).
28. Acute illness, active infection, or sepsis.
29. Life expectancy less than 12 months.
30. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.
31. Body mass index \>45 kg/m2.
32. Known ongoing drug or alcohol dependency.
33. Current or anticipated participation in any other ongoing study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
34. Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).
35. Any other condition that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would pose a significant hazard to the subject if an ablation procedure were performed.

Where this trial is running

Boston, Massachusetts and 5 other locations

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Vivek Reddy, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Josh Treadway

Conditions: Ventricular Tachycardia, Recurrent sustained monomorphic ventricular tachycardia, Monomorphic ventricular tachycardia, Ventricular tachycardia, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes