Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured.
研究概览
简要总结
A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).
详细描述
Atrial Fibrillation is the commonest arrhythmia and is a major cause of morbidity and mortality, often causative in ischaemic strokes and compounded by heart failure. Treatment options are limited for persistent long-standing AF (PeAF), with pulmonary vein isolation by endocardial ablation being insufficient and further additive endocardial lesions with repeated ablations yield mixed results resultant in further atrial arrhythmias. Currently success rates for catheter ablation are moderate at 40 to 70% in a single procedure.
If this was improved, patient quality of life and readmission rates would significantly improve as well as a reduction in anti-arrhythmic drug use.
The Convergent procedure - is a two stage minimally invasive hybrid approach. The first stage employs surgical ablation to the posterior wall of the left atrium in combination with the LARIAT procedure to isolate the left atrium appendage (LAA). The second stage involves endocardial catheter ablation to confirm the surgical ablation lesions, and perform further endocardial catheter ablation to leverage both epicardial and endocardial lesions to create durable, transmural lesions.
Patients with long-standing persistent AF will be randomised in a 1:1 ratio to either the Convergent ablation with the LARIAT procedure or the standard endocardial catheter ablation.
This feasibility study would assess recruitment to the trial, safety and efficacy of the Convergent procedure, in combination with a left atrial appendage system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years; < 80 years
- •Persistent AF > 1-year duration
- •Left atrium size < 6cm
- •Pts should be able to provide written informed consent.
排除标准
- •Subjects currently enrolled in another investigational study except in case of observational registry with no associated treatments.
- •Subject has a reversible cause of AF or transient AF
- •Subject is absent of LAA or if the LAA is previously surgically ligated
- •Subject has had previous cardiac surgery or abdominal surgery.
- •Subject has contraindication to anticoagulation.
- •Patients with hypertrophic cardiomyopathy.
- •Patients with significant valve disease.
- •Subject has had previous catheter or surgical ablation
研究组 & 干预措施
Convergent AF Ablation with Left Atrial Appendage Exclusion
Two Staged Convergent AF Ablation Procedure
Stage 1 - Minimally Invasive Surgical Epicardial Ablation Procedure with concomitant LAA exclusion (LARIAT procedure)
Stage 2 - Percutaneous Endocardial Catheter Ablation
干预措施: Epicardial AF ablation using AtriCure EPi-Sense-AF Guided Coagulation System with Left Atrial Appendage Exclusion using the AtriCure LARIAT Suture Delivery Device. (Device)
Convergent AF Ablation with Left Atrial Appendage Exclusion
Two Staged Convergent AF Ablation Procedure
Stage 1 - Minimally Invasive Surgical Epicardial Ablation Procedure with concomitant LAA exclusion (LARIAT procedure)
Stage 2 - Percutaneous Endocardial Catheter Ablation
干预措施: Standard Endocardial Catheter Ablation (Procedure)
Standard Endocardial Catheter Ablation
Standard Endocardial Catheter Ablation
干预措施: Standard Endocardial Catheter Ablation (Procedure)
结局指标
主要结局
A composite of major adverse events (MAE) and complications occurring within 30 days post procedure will be measured.
时间窗: 30 days post procedure
Primary safety endpoint was a composite of major adverse events (MAE) and complications occurring within 30 days post procedure. Any of the following endpoints counted as a MAE: death, stroke/transient ischaemic attack, myocardial infarction, pericarditis requiring pericardiocentesis or prolongation of hospital stay or readmission, cardiac perforation/tamponade, bleeding at vascular access site requiring intervention, pneumothorax requiring intervention (after removal of chest drain, symptomatic pulmonary vein stenosis \> 70%, permanent phrenic nerve paralysis, atrio-oesophageal fistula, major vascular complications and infection at surgical or puncture site requiring surgical intervention.
Demonstrate trial feasibility with regards to recruitment rate
时间窗: 24 months
Recruitment rate to the Convergent Procedure (with LARIAT) and radiofrequency ablation in the cohort of patients with our specific inclusion criteria will be measured.
Measure improvement in symptoms following convergent ablation
时间窗: 12 months
Measure change in quality of life through the European Heart Rhythm Association (EHRA) patient survey which categorises patients symptoms during physical activity in 4 categories. The higher the class, the greater the severity of symptoms with Class 1 indication no symptoms and Class 4 indicating disabling symptoms with discontinuation of normal daily activity.
Success or failure at 12 months of persistent AF patients to be free of: Atrial arrhythmia (classed as documentation of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds)
时间窗: Measured from the end of a 3 month blanking period to 12 months post procedure
Recurrence of any atrial arrhythmia \> 30 seconds on or off class I / III medications
次要结局
- Measure improvement in NYHA (New York Heart Association) class in patients with NYHA class III to IV following convergent AF ablation.(12 months)
- Measure improvement in symptoms following convergent ablation.(12 months)
- Changes in baseline left ventricular ejection fraction (LVEF) in patients with severe left ventricular systolic dysfunction (EF <35%) will be measured.(12 months)