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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Sphere-9 Catheter with the Affera Mapping and Ablation System
  Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and undergo ablation with the Sphere-9 Catheter with the Affera Mapping and Ablation System.

Первичные конечные точки

• Primary Safety Endpoint: evaluate the safety of the index ablation procedure [Срок оценки: Within 7 days post-procedure]
• Primary Effectiveness Endpoint: assess acute procedural success of the index ablation procedure [Срок оценки: Day of ablation procedure]

Вторичные конечные точки (1)

• Secondary Endpoint: assess chronic effectiveness of the index ablation procedure [Срок оценки: Within 6 months post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Beth Israel Deaconess Medical Center — Boston
• Icahn School of Medicine at Mount Sinai — New York
• Cleveland Clinic Foundation — Cleveland
• Hospital of the University of Pennsylvania — Philadelphia
• Vanderbilt University Medical Center — Nashville
• Texas Cardiac Arrhythmia Research Foundation — Austin

Идентификаторы

NCT: NCT06703489 · Sphere-9 VT EFS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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