Actively Recruiting
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Led by Medtronic Cardiac Ablation Solutions · Updated on 2026-03-05
60
Participants Needed
6
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
CONDITIONS
Official 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 through 85 years
- Diagnosis of ischemic cardiomyopathy with prior myocardial infarction or non-ischemic cardiomyopathy with documented myocardial scar
- At least one episode of sustained monomorphic ventricular tachycardia lasting more than 30 seconds or requiring ICD intervention within 6 months prior to enrollment
- Recurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or ICD intervention
- Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 3 months prior to the ablation procedure
- 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, automaticity, triggered activity, certain genetic mutations, electrolyte imbalance, active thyroid disease, or other reversible/non-cardiac causes
- Active inflammatory processes such as myocarditis within 120 days before ablation in non-ischemic cardiomyopathy patients
- Ventricular tachycardia or fibrillation from channelopathies
- More than two prior VT ablations ever, more than one within 12 months, or any within 4 weeks before ablation
- Sarcoidosis
- Hypertrophic cardiomyopathy except when caused by apical aneurysm
- Unstable angina or active myocardial ischemia
- Type 1 myocardial infarction within 60 days prior to ablation
- Percutaneous coronary intervention within 60 days prior to ablation
- Cardiac surgery within 90 days prior to ablation
- Left ventricular ejection fraction less than 15%
- NYHA Class IV heart failure or decompensated heart failure
- Receiving or expected to receive ECMO support before ablation
- Ventricular assist device implanted, planned, or required
- Severe aortic or mitral valve stenosis or regurgitation
- Presence of prosthetic aortic or mitral valve
- Advanced COPD requiring home oxygen
- Intracardiac thrombus, tumor, or abnormalities preventing catheter use
- Stroke or transient ischemic attack within 180 days prior to ablation or with neurologic deficit
- Left atrium or left ventricle intracardiac thrombus on imaging
- Severe bleeding, clotting, thrombotic disorders, or thrombocytopenia with platelet count less than 80,000
- Contraindication to anticoagulation
- End-stage renal disease requiring dialysis
- Acute illness, active infection, or sepsis
- Life expectancy under 12 months
- Pregnancy, breastfeeding, or unreliable birth control in women of childbearing potential
- Body mass index over 45 kg/m2
- Known ongoing drug or alcohol dependency
- Participation in other ongoing studies not approved by the Sponsor
- Vulnerable subjects such as prisoners, handicapped or mentally disabled persons, or those under guardianship
- Any other condition that may prevent study enrollment, compliance, or pose significant hazard with ablation
AI-Screening
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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
CONTACT
A
Analyn Jackson
CONTACT
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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