Actively Recruiting
Safety and Performance Assessment of the Sphere-9 Catheter and Affera Ablation System for the Treatment of Ventricular Tachycardia
Led by Medtronic Cardiac Ablation Solutions · Updated on 2026-03-05
60
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Sphere-9 Catheter combined with the Affera Mapping and Ablation System for treating adults with recurrent, sustained, scar-related monomorphic ventricular tachycardia. This prospective, multi-center, non-randomized, unblinded feasibility study focuses on adults aged 18 to 85 years with ventricular tachycardia who have already undergone certain treatments. The study aims to assess both the safety and effectiveness of this specific catheter ablation procedure. Participants will undergo a catheter ablation using the Sphere-9 Catheter with the Affera Mapping and Ablation System to treat ventricular tachycardia. The procedure is designed for patients who have had sustained ventricular tachycardia episodes despite medication or implantable cardiac defibrillator intervention. The primary safety endpoint will be evaluated within 7 days after the ablation procedure, while the primary effectiveness endpoint will be assessed on the day of the procedure. Additional follow-up will monitor chronic effectiveness within 6 months post-procedure. During the study, participants will be monitored closely with safety and effectiveness assessments at specified intervals, including immediately on the day of the procedure, within 7 days afterward, and up to 6 months post-procedure. These assessments aim to track procedural success and any safety concerns. Participants will need to comply with all pre-, post-, and follow-up testing requirements, including providing informed consent and attending study visits until the study ends in January 2027.
CONDITIONS
Brief Title
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 85 years old
- History of ischemic or non-ischemic cardiomyopathy with documented myocardial scar
- At least one episode of sustained monomorphic ventricular tachycardia within 6 months prior to enrollment
- Recurrence of ventricular tachycardia despite class I or III antiarrhythmic drugs or ICD intervention
- Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 3 months
- Willing and able to provide informed consent
- Willing and able to comply with all pre-, post-, and follow-up testing requirements
You will not qualify if you...
- Incessant ventricular tachycardia requiring hemodynamic support before ablation
- Unstable polymorphic ventricular tachycardia or ventricular fibrillation
- Ventricular tachycardia due to idiopathic causes, genetic mutations, electrolyte imbalance, active thyroid disease, or reversible/non-cardiac causes
- Active inflammatory processes in non-ischemic cardiomyopathy within 120 days prior to ablation
- Ventricular tachycardia or fibrillation related to channelopathies
- More than two prior ventricular tachycardia ablations ever, more than one in last 12 months, or any ablation within 4 weeks prior
- Sarcoidosis
- Hypertrophic cardiomyopathy except with apical aneurysm
- Unstable angina or active myocardial ischemia
- Recent myocardial infarction or cardiac procedures within 2 to 3 months
- Left ventricular ejection fraction below 15%
- NYHA Class IV or decompensated heart failure
- Extracorporeal membrane oxygenation (ECMO) support or ventricular assist device (VAD) implanted or planned
- Severe aortic or mitral valve stenosis or regurgitation, or prosthetic valves
- Advanced COPD requiring home oxygen
- Intracardiac thrombus, tumor, or other vascular access issues
- Recent thromboembolic events or intracardiac thrombus on imaging
- Severe bleeding or clotting disorders or contraindication to anticoagulation
- End-stage renal disease requiring dialysis
- Acute illness, infection, or sepsis
- Life expectancy less than 12 months
- Pregnant or breastfeeding women or those not using reliable birth control
- Body mass index over 45 kg/m2
- Known drug or alcohol dependency
- Participation in other unapproved studies
- Vulnerable subjects such as prisoners or mentally disabled persons
- Any condition posing significant hazard or affecting compliance with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of ablation procedure
Participants undergo ablation with the Sphere-9 Catheter using the Affera Mapping and Ablation System to treat ventricular tachycardia.
1 procedure visit (in-person)
Duration - Up to 6 months post-procedure
Participants are monitored for safety and effectiveness of the ablation procedure, including assessments within 7 days and up to 6 months post-procedure.
Approximately 3 to 4 visits over 6 months
Trial Site Locations
Total: 6 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
3
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
4
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
6
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Not Yet Recruiting
Research Team
J
Josh Treadway
A
Analyn Jackson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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