Prospective Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF (STSF) Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 381
- 主要终点
- Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days
研究概览
简要总结
This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
详细描述
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial fibrillation (PsAF) following standard electrophysiology mapping and radio frequency (RF) ablation procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for this study must meet ALL of the following criteria:
- •Documented symptomatic persistent AF, which is defined as continuous AF sustains beyond 7 days and less than 1 year and is documented by the following:.
- •Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND
- •Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR
- •24-hour Holter within 90 days of the ablation procedure showing continuous AF
- •Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
- •Age 18 years or older.
- •Signed Patient Informed Consent Form (ICF).
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
排除标准
- •Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:
- •Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
- •Previous surgical or catheter ablation for atrial fibrillation
- •Any cardiac surgery within the past 2 months (60 days) (includes percutaneous coronary intervention (PCI))
- •Coronary Artery Bypass Graft (CABG) surgery within the past 6 months (180 days)
- •Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
- •Any carotid stenting or endarterectomy
- •Documented left atrial (LA) thrombus on imaging
- •LA size > 50 mm (parasternal long axis view)
- •Left ventricular ejection fraction (LVEF) < 40%
- •Contraindication to anticoagulation (heparin or warfarin)
- •History of blood clotting or bleeding abnormalities
- •MI within the past 2 months (60 days)
- •Documented thromboembolic event (including Transient Ischemic Attack (TIA) within the past 12 months (365 days)
- •Rheumatic Heart Disease
- •Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV
- •Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥ 50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- •Unstable angina
- •Acute illness or active systemic infection or sepsis
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- •Diagnosed atrial myxoma.
- •Presence of implanted implantable cardioverter defibrillator (ICD) /cardiac resynchronization therapy defibrillator (CRT-D).
- •Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- •Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including over-the-counter (OTC) medication)
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- •Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
- •Enrollment in an investigational study evaluating another device, biologic, or drug.
- •Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
- •Presence of any other condition that precludes appropriate vascular access.
- •Life expectancy less than 12 months
结局指标
主要结局
Primary Safety Endpoint - Percentage of Participants With Any PAE Within 7 Days
时间窗: 7 days (except as noted in analysis population description)
The primary safety endpoint is the incidence of any early onset (within 7 days of the initial and repeat AF ablation procedure) Primary Adverse Events (AE), which are listed below: * Death * Atrio-esophageal fistula\* * Cardiac Tamponade\*\*+/Perforation+ * Myocardial infarction (MI) * Stroke / Cerebrovascular accident (CVA) †, †† * Thromboembolism * Transient Ischemic Attack * Diaphragmatic paralysis * Pneumothorax * Heart block * PV stenosis\* * Pulmonary edema (Respiratory Insufficiency) * Pericarditis * Major Vascular access complication / bleeding
Effectiveness: Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 15-month Follow-up
时间窗: 15-month follow-up
The primary effectiveness endpoint for this study will be freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 15-month follow-up (post 3-Month Medication Adjustment Period followed by a 3-Month Therapy Consolidation period (Day 181-450)) and freedom from the following failure modes: * Acute Procedural Failure * Non-Study Catheter Failure * Repeat Ablation Failure * AAD Failure * Surgical Failure
次要结局
- Acute Procedural Success(Immediate post-procedure)
- Late Onset Serious Adverse Event (SAE)(>30 days up to 15 months)
- 15-Month Single Procedure Success(15-Month)
- Peri-Procedural Serious Adverse Event (SAE)(>7 to 30 days)
- Early Onset Serious Adverse Event (SAE)(7 days)