Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 58
- 主要终点
- Number of Participants with Primary Adverse Events (PAEs)
研究概览
简要总结
The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) with (a) at least two symptomatic atrial fibrillation (AF) episodes within last six months from enrollment and (b) at least one AF episode electrocardiographically documented by electrocardiogram (ECG); transtelephonic monitoring (TTM), Holter monitor, telemetry strip or implanted device within 12 months prior to enrollment
- •Failed at least one antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable side effects to the AAD, or contraindication to the AAD
- •Willing and capable of providing consent
- •Able and willing to comply with all pre-, post- and follow-up testing and requirements
排除标准
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)
- •Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
- •Previous left atrium (LA) ablation or surgery
- •Participants known to require ablation outside the pulmonary vein (PV) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia, and Wolff-Parkinson-White), except cavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter
- •Documented severe dilatation of the LA (left anterior descending artery [LAD] >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment
- •Documented LA thrombus by imaging within 48 hours of the procedure
- •Documented severely compromised left ventricular ejection fraction (LVEF less than [<] 40 percent [%]) by imaging within 6 months prior to enrollment
- •Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- •History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin) except subjects with prior left atrial appendage closure
- •Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months
- •Participants with unstable angina, percutaneous coronary intervention or acute myocardial infarction within 2 months
- •Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)
- •Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
- •Unstable angina within 6 months
- •Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
- •Significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- •Significant congenital anomaly (for example, atrial septal defects [ASDs]) including repaired defects or medical problem that in the opinion of the investigator would preclude enrollment in this study
- •Prior diagnosis of pulmonary vein stenosis
- •Pre-existing hemi diaphragmatic paralysis
- •Acute illness, active systemic infection, or sepsis
- •Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- •Severe mitral regurgitation (Regurgitant volume greater than or equal to [>=] 60 milli liter (mL)/beat, Regurgitant fraction >= 50%, and/or Effective regurgitant orifice area >= 0.40 cm^2)
- •Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD), recently implanted (within 6 months) left atrial appendage occlusion (LAAO) device or other implanted metal cardiac device within cardiac space that may interfere with the energy field created during the ablation procedure
- •Presence of a condition that precludes vascular access
- •Current enrollment in an investigational study evaluating another device or drug
- •Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
- •Life expectancy less than 12 months
- •Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)
研究组 & 干预措施
Treatment Group
Participants with drug refractory, symptomatic paroxysmal atrial fibrillation will receive PFA /radiofrequency (RF) ablation using THERMOCOOL STSF catheter in conjunction with the TRUPULSE generator per the hospital's standard protocol (at discretion of investigator).
干预措施: THERMOCOOL STSF Bi- Directional Navigation Catheter (Device)
Treatment Group
Participants with drug refractory, symptomatic paroxysmal atrial fibrillation will receive PFA /radiofrequency (RF) ablation using THERMOCOOL STSF catheter in conjunction with the TRUPULSE generator per the hospital's standard protocol (at discretion of investigator).
干预措施: TRUPULSE Generator (Device)
结局指标
主要结局
Number of Participants with Primary Adverse Events (PAEs)
时间窗: 7 days post-procedure
PAEs occurring within 7 days of an ablation which uses the BWI ablation system (including atrio-esophageal fistula and pulmonary vein stenosis occurring greater than 7 days of post ablation procedure) will be reported.
Percentage of Participants with Freedom from Documented (Symptomatic and Asymptomatic) Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes and Other Failure Modes
时间窗: Up to 274 days
The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic AF, AT, or AFL will be reported.
次要结局
- Change From Baseline in Quality-of-Life (QOL) Improvement(From baseline to 12 months post ablation procedure)