Sphere-9 VT
Study on Investigational Catheter for Scar-Related Ventricular Tachycardia
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Ventricular Tachycardia (VT)
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Age: 18 years - 85 years
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Gender: All
Inclusion Criteria:
- Any of the following:
- Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI).
- Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging.
- 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 3 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 Criteria:
- Incessant VT necessitating hemodynamic support prior to the ablation procedure.
- Unstable polymorphic VT or ventricular fibrillation (VF).
- VTs due to any of the following:
- Idiopathic VT
- Automaticity or triggered activity
- Lamin or titin genetic mutation
- Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).
- NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days
prior to the ablation procedure.
- VT or VF thought to be from channelopathies.
- 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.
- Sarcoidosis.
- Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
- Unstable angina.
- Active myocardial ischemia.
- Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
- Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.
- Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
- Left ventricular ejection fraction (LVEF) <15%.
- NYHA Class IV heart failure.
- Decompensated heart failure.
- Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
- Ventricular assist device (VAD) implanted, planned or required for the procedure.
- 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 thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
- Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.
- Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count <80,000).
- Contraindication to anticoagulation.
- End-stage renal disease (requiring dialysis).
- Acute illness, active infection, or sepsis.
- 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.
- 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.
- Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).
- 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.
This study investigates the use of an investigational catheter and ablation system for individuals with scar-related monomorphic ventricular tachycardia.
The purpose of this study is to evaluate the feasibility of using the Sphere-9 Catheter and Affera Ablation System for treating this condition. The study will focus on assessing the safety and potential effectiveness of this investigational treatment.
- Who can participate: Adults aged 18 to 85 years with a history of ischemic or non-ischemic cardiomyopathy and recurrent ventricular tachycardia may be eligible. Participants must have an implantable cardiac defibrillator and be able to provide informed consent.
- Study details: Participants will undergo a procedure using the investigational catheter and Affera Ablation System.
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