PeAF-Box. A Study to Investigate the Feasibility, Safety and Efficacy of Isolating the Left Atrial Posterior Wall Adjunctive to Pulmonary Vein Isolation as First-line Therapeutical Strategy in Treatment of Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- The safety of single procedure PVI + PWI
研究概览
简要总结
Title: PeAF-Box. Feasibility, Safety and Efficacy of Isolating the Left Atrial Posterior Wall (PWI) added to Pulmonary Vein Isolation (PVI) as First-Line Strategy in Treatment of Persistent Atrial Fibrillation (PeAF)
Design: A prospective, observational, single center, unblinded, clinical study with 3 years of follow-up and two interventional procedures: An index ablation procedure and a reassessment/ reablation procedure after 6 months.
Background: In patients with PeAF the effect of first-line ablation with pulmonary vein isolation (PVI) is smaller than in patients with paroxysmal atrial fibrillation (PAF), where PVI alone is effective in reducing symptoms and increasing quality of life. Adding PWI to PVI is increasingly used despite concerns about safety and efficacy.
Objectives: (1) To use PVI + PWI as first-line ablation-strategy in participants with PeAF and to assess the feasibility of obtaining that goal. (2) To assess the safety of applying this lesion set - in terms of heat-induced injury to the esophagus - using esophagoscopy. 3) To asses arrhythmia burden using continuous monitoring for 3 years after ablation. (4) To assess the durability of the PVI + PWI lesion set by a relook/ reablation procedure after 6 months. (5) To follow the effect of PVI + PWI on participants' quality of life over three years.
Study site: Dept of Cardiology - Electrophysiology Laboratory, Gentofte Hospital, University of Copenhagen.
Study population: 24 patients referred for ablation of PeAF are asked for informed consent for these elements that surpass standard treatment in PeAF: (1) Taking amiodarone for 3 weeks prior to the index procedure to 3 weeks after the procedure, (2) Additional ablation with PWI compared to standard first-line therapy with PVI only. (3) Implantation of an implantable cardiac monitor (ICM), (4) Post-procedure esophagoscopy, (5) Regular clinic visits for 3 years post procedure, (6) Undergoing an interventional relook/ reablation procedure 6 months after the index procedure.
Anticoagulation drugs during the procedure and follow up: To prevent thromboses participants are prescribed periprocedural oral anticoagulant treatment to be continued for shorter or longer/lifelong periods according to the participants' risk of thrombosis (the CHA2DS2-VASC score).
Anti-arrhythmic drugs (AADs): Except from periprocedural amiodarone treatment, no AADs are allowed during the follow-up apart from occurrence of otherwise untreatable arrhythmias.
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
- •Patients with symptomatic persistent atrial fibrillation (EHRA symptom class II or above)
- •Prior failed treatment with at last one antiarrhythmic drug (Class I-IV)
- •Clinical indication for ablation
- •Persistent atrial fibrillation meeting both the following requirements:
- •One or more episodes of atrial fibrillation lasting longer than seven days, regardless of mode of termination
- •Estimated cumulated time in PeAF more than 3 months and less than 36 months
排除标准
- •Contraindication for ablation
- •Predominantly PAF phenotype
- •Valvular Heart disease
- •Previous ablation in heart
- •Previous heart surgery (including valve surgery and coronary artery bypass grafting - CABG)
- •Documented atrial flutter or other arrhythmia requiring ablation besides PVI
- •Greatly enlarged left atrium on Trans thoracic Echocardiography (TTE ; diameter > 52 mm in males and diameter > 47 mm in females)
- •LVEF < 35%
- •Implanted pacemaker or defibrillator
- •Presence of intramural thombus, tumor or other abnormality precluding catheter introduction
- •Pregnancy
- •Intolerance to Amiodarone
- •Unstable angina pectoris
- •Myocardial infarction within 3 months of inclusion
- •History of blood clotting or bleeding anomalies
- •Malignant disease (non metastatic skin cancer excluded)
- •Severe obesity (Mody mass index > 35 kg/m^2)
- •Active systemic infection
- •Renal insufficiency (serum creatinine > 150 mmoles/liter)
- •Psychiatric illness
- •Substance abuse
- •Participation in other clinical trials
结局指标
主要结局
The safety of single procedure PVI + PWI
时间窗: Esophagoscopy is carried out at least 20 hours and less than 48 hours after the index ablation procedure
Defined as the incidence of inflammation or other injury to the esophagus detected under mandated esophagoscopy on the day after PVI + PWI with radiofrequency ablation. The endoscopy is carried out, assessed and electronically stored by a board-certified gastroenterologist. Metric: n/N in %.
次要结局
- AF recurrence long term(The data are available 1080 days after the index procedure)
- Feasibility of a first-procedure PVI + PWI strategy(The data are available immediately after the end of the index PVI + PWI procedure)
- Durability of the PVI + PWI lesion set(The data are available immediately after the end of the six months reassessment procedure)
- AF burden short term(The data are available 180 days after the index procedure)
- AF recurrence short term(The data are available 180 days after the index procedure)
- AF burden long term(The data are available 1080 days after the index procedure)
- Temperature in the esophagus during radiofrequency ablation(The data are available immediately after the end of the index PVI + PWI procedure)
- Long term efficacy PVI + PWI(The data are available 1080 days after the index procedure)
- Effect on quality of life by PVI + PWI(Data are available from recruitment to end of follow-up at 3 years)
研究者
René Husted Worck
M.D. Consultant in Cardiology and Cardiac Electrophysiology
University Hospital, Gentofte, Copenhagen