RECRUITING

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

Conditions

Ventricular Tachycardia (VT)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)Ischemic cardiomyopathy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-18

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06703489

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Prior myocardial infarction (MI). 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.	1. Incessant VT necessitating hemodynamic support prior to the ablation procedure. 2. Unstable polymorphic VT or ventricular fibrillation (VF). 3. Idiopathic VT or VT of non-ischemic cardiomyopathy. 4. Known reversible cause of VT (e.g., electrolyte abnormalities, drug induced arrhythmia). 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. 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. 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.

Inclusion Criteria

Exclusion Criteria

1. Prior myocardial infarction (MI).
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.

1. Incessant VT necessitating hemodynamic support prior to the ablation procedure.
2. Unstable polymorphic VT or ventricular fibrillation (VF).
3. Idiopathic VT or VT of non-ischemic cardiomyopathy.
4. Known reversible cause of VT (e.g., electrolyte abnormalities, drug induced arrhythmia).
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.
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. 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.

Contacts and Locations

Study Contact

Josh Treadway

CONTACT

817-412-0608

josh.b.treadway@medtronic.com

Principal Investigator

Vivek Reddy, MD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Medtronic Cardiac Ablation Solutions

Vivek Reddy, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-18

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-03-18

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

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)
Ischemic cardiomyopathy

Additional Relevant MeSH Terms

Ventricular Tachycardia (VT)