Medtronic Terminate AF Study

Официальное название

Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)

Обзор

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).

Подробное описание

This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the United States (US). The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months.

The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.

Вмешательства

• Процедура Surgical Ablation
  In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.
• Устройство Cardioblate and Cryoflex hand held devices
  The Cardioblate hand held devices consist of the Cardioblate iRF and Cryoflex surgical ablation devices.

Первичные конечные точки

• Composite acute major adverse event rate [Срок оценки: 30-days post-procedure or hospital discharge (whichever is longer)]
• Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT) [Срок оценки: 6-months post-procedure to 12-months post-procedure]

Вторичные конечные точки (9)

• Composite acute major adverse event rate (Safety) [Срок оценки: 6-months post-procedure]
• Composite acute major adverse event rate (Safety) [Срок оценки: 12-months post-procedure]
• Percentage of new permanent pacemaker implantation (Safety) [Срок оценки: 12-months post-procedure]
• Acute procedural success (Efficacy) [Срок оценки: During index procedure]
• Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy) [Срок оценки: 6-months post-procedure]
• Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy) [Срок оценки: 6-months post-procedure]
• Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy) [Срок оценки: 12-months post-procedure]
• Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Quality of Life Score over time (Efficacy) [Срок оценки: 12-months post-procedure]
• SF-12 Health Survey (SF-12) Quality of Life Score over time (Efficacy) [Срок оценки: 12-months post-procedure]

Критерии участия

Критерии включения

• History of non-paroxysmal AF (persistent or longstanding persistent)
• Concomitant indication for non-emergent open-heart surgery, eg,

• Coronary artery bypass grafting
• Valve repair or replacement
• Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)

Критерии исключения

• Wolff-Parkinson-White syndrome
• New York Heart Association (NYHA) Class = IV
• Left Ventricular Ejection Fraction ≤ 30%
• Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
• Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Maze procedure
• Contraindication for anticoagulation therapy
• Left atrial diameter > 6.0 cm
• Preoperative need for an intra-aortic balloon pump or intravenous inotropes
• Renal failure requiring dialysis or hepatic failure
• Life expectancy of less than 1 year
• Predicted risk of operative mortality >10% as assessed by STS Risk Calculator
• Pregnancy or desire to be pregnant within 12 months of the study treatment
• Current diagnosis of active systemic infection
• Active endocarditis
• Documented MI 30 days prior to study enrollment
• Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias

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 · 15 центров

• Stanford Hospitals and Clinic — Palo Alto
• Adventist Health St. Helena — St. Helena
• Hartford Healthcare — Hartford
• St Vincent Heart Center of Indiana — Indianapolis
• Massachusetts General Hospital — Boston
• Corewell Health — Grand Rapids
• Washington University School of Medicine — St Louis
• ProMedica Toledo — Toledo
• … и ещё 7 центров

Идентификаторы

NCT: NCT03546374 · MDT17066ECT001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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