Clinical trial NCT06703489: Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
Official title: Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia (VT)
Keywords: Recurrent sustained monomorphic ventricular tachycardia
Monomorphic ventricular tachycardia
Ventricular tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ischemic heart disease
Patient with Implantable Cardioverter Defibrillator (ICD)
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2024-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Prior myocardial infarction.
2. At least one episode of sustained (continuous for \>30 seconds, or requiring implantable cardiac defibrillator intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment.
3. Spontaneous occurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or implantable cardiac defibrillator intervention.
4. Implanted with an implantable cardiac defibrillator or cardiac resynchronization therapy defibrillator 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 ventricular tachycardia necessitating hemodynamic support prior to the ablation procedure.
2. Unstable polymorphic ventricular tachycardia or ventricular fibrillation.
3. Idiopathic ventricular tachycardia or ventricular tachycardia of non-ischemic cardiomyopathy.
4. Known reversible cause of ventricular tachycardia (e.g., electrolyte abnormalities, drug induced arrhythmia).
5. Ventricular tachycardia or ventricular fibrillation thought to be from channelopathies.
6. More than one prior ventricular tachycardia ablation at any time, or any ventricular tachycardia ablation within 6 months prior to the ablation procedure.
7. Unstable angina.
8. Active myocardial ischemia.
9. Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
10. Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.
11. Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
12. Left ventricular ejection fraction \<15%.
13. New York Heart Association Class IV heart failure.
14. Decompensated heart failure.
15. Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation.
16. Ventricular assist device implanted, planned or required for the procedure.
17. Severe aortic stenosis or flail mitral valve.
18. Presence of prosthetic valve in the aortic or mitral valve.
19. Patients with advanced chronic obstructive pulmonary disease (on home oxygen).
20. Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
21. Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
22. Intracardiac thrombus on imaging.
23. Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \<80,000).
24. Contraindication to anticoagulation.
25. End-stage renal disease (requiring dialysis).
26. Acute illness, active infection, or sepsis.
27. Life expectancy less than 12 months.
28. 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.
29. Body mass index \>45 kg/m².
30. Known ongoing drug or alcohol dependency.
31. 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.
32. Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).
33. 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.

Primary outcomes:
measure: Primary Safety Endpoint: evaluate the safety of the index ablation procedure
timeFrame: Within 7 days post-procedure
measure: Primary Effectiveness Endpoint: assess acute procedural success of the index ablation procedure
timeFrame: Day of ablation procedure
Secondary outcomes:
measure: Secondary Endpoint: assess chronic effectiveness of the index ablation procedure
timeFrame: Within 6 months post-procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: