Testing a Heart Ablation Catheter for Ventricular Tachycardia After Heart Attack
Tests a heart ablation catheter in adults with ventricular tachycardia after a heart attack.
Plain-language title generated from the registry record
Registry title: Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Key facts
- Where
- Austin, Columbus, Indianapolis, Littleton, Manhasset, New York, and Winston-Salem, United StatesSee the 7 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07585968, who can take part
Where in United States
- Texas Cardiac Arrhythmia Research FoundationAustin, United StatesTaking people
- The Ohio State University -Wexner Medical CenterColumbus, United StatesTaking people
- Ascension Saint Vincent Hospital - IndianapolisIndianapolis, United StatesTaking people
- South Denver Cardiology AssociatesLittleton, United StatesNo longer taking part
- Northwell Health Lenox Hill HospitalManhasset, United StatesTaking people
- NYU Langone Medical CenterNew York, United StatesNo longer taking part
- Atrium Health Wake Forest Baptist Medical CenterWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medtronic Cardiac Ablation Solutions
- Trial code
- NCT07585968
- Record updated
- 26 October 2026
- Original description
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.Read full original descriptionShow less
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
Inclusion: Prior myocardial infarction (MI); 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; 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 2 months prior to the ablation procedure; Age 18 through 85 years old; Willing and able to provide informed consent; Willing and able to comply with all pre-, post-, and follow-up testing requirements.
Exclusion: Incessant VT necessitating hemodynamic support prior to the ablation procedure; 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; Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure; Any percutaneous coronary intervention performed in a setting of unstable angina or acute MI (STEMI or non-STEMI) within 2 months (60 days) prior to the ablation procedure. Note: elective PCI performed during elective angiogram would be excluded only if occurring within 30 days prior to the ablation procedure; Any cardiac surgery within 2 months (60 days) prior to the ablation procedure. Note: ICD lead implant/replacement falls under this exclusion, but ICD generator-only replacement does not; Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO); Circulatory/ventricular assist device (VAD; surgical or percutaneous) implanted, planned or required for the procedure; Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit; Known ongoing drug or alcohol dependency; 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; VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia); Unstable angina; Active myocardial ischemia; NYHA Class IV heart failure; Decompensated heart failure; End-stage renal disease (requiring dialysis); Acute illness, active infection, or sepsis; 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; Left ventricular ejection fraction (LVEF) <15%; Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count <80,000); Unstable polymorphic VT or ventricular fibrillation (VF); Idiopathic VT or VT of non-ischemic cardiomyopathy; VT or VF thought to be from channelopathies; Sarcoidosis; Hypertrophic cardiomyopathy, except when due to an apical aneurysm; Extravascular ICD (EV-ICD) or subcutaneous ICD (S-ICD); Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation; Presence of prosthetic valve in the aortic or mitral valve; Patients with advanced COPD (on home oxygen); Presence of intracardiac tumor or other abnormality that precludes vascular access, catheter introduction, or manipulation; Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging; Contraindication to anticoagulation; Life expectancy less than 12 months; 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; Body mass index >45 kg/m2; Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).