跳至主要内容
临床试验/NCT04506814
NCT04506814撤回不适用

Comparison of Repeat Endocardial PVI Vs Epicardial Posterior Wall Isolation and LAA Clip Plus PVI for Recurrent Atrial Fibrillation After Prior PVI

University of Rochester1 个研究点 分布在 1 个国家开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Atrial fibrillation > 30 secs

研究概览

简要总结

There is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI). This study will compare redo PVI with hybrid epicardial ablation incorporating posterior wall isolation and LAA clip, and redo PVI.

详细描述

In these redo ablation patients, the ideal re-ablation strategy is unknown and many techniques have been proposed but there is no consensus nor strong clinical trial data.

This treatment gap prompted the development of a combined minimally invasive epicardial and endocardial ablation ("Convergent") procedure. During the last decade, this "hybrid" approach has garnered increasing acceptance in clinical practice, with several reports of promising antiarrhythmic outcomes in challenging disease states, as well as modifications to maximize safety and clinical outcomes. One key aspect of this approach is that it targets key drivers of AF including the PVs but also the left atrial posterior wall (LAPW), combining endocardial and epicardial energy delivery. The LAPW (or "PV myocardium") shares similar embryological origins and electrophysiological properties with the PVs, is predisposed to develop fibrosis, and thus recognized as an important source of AF. Recently, the CONVERGE randomized clinical trial demonstrated superiority of this hybrid approach compared to PVI in patients with persistent AF.

The left atrial appendage (LAA) has also been designated as a potential important trigger site of AF, and if isolated, may result in improved post-ablation AF outcomes. Although catheter-based isolation is controversial due to the potential to increase the risk of stroke, surgical exclusion of the LAA by placement of an occlusive clip has been suggested to be both antiarrhythmic and anti-thrombotic. Thus it is proposed in this trial to incorporate the LAA clip within the hybrid procedure.

Given the sheer volume of patients undergoing ablation of AF and the predictable necessity to perform repeat ablation procedures on a portion of these patients, the need for a proven redo ablation strategy is self-evident. The investigators thus propose a randomized clinical trial to determine if there is incremental efficacy by performing LAPW/LAA isolation via a hybrid approach in comparison to the conventional redo PVI alone in patients with paroxysmal AF.

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
Single (Outcomes Assessor)

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
否

入选标准

  • •Age > 18 years
  • •Symptomatic paroxysmal AF despite prior 1 or 2 PVI procedures within past 10 years (paroxysmal AF lasting up to 7 days before spontaneous termination)
  • •Eligible for referral for re-ablation based on current guidelines
  • •LA diameter < 6.0 cms on transthoracic echo
  • •Willingness to comply with post-procedural follow-up requirements and to sign informed consent

排除标准

  • •Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to anticoagulation)
  • •Prior history of open heart surgery
  • •Prior history of pericarditis or pericardiocentesis
  • •Prior history of stroke/TIA/systemic embolism
  • •NYHA class IV congestive heart failure or LVEF < 25%
  • •Persistent or longstanding persistent AF (duration > 1 year)
  • •Coronary revascularization or valve surgery within 3 months
  • •Prior valve surgery using a mechanical prosthesis
  • •An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
  • •Life expectancy <1 year for any medical condition
  • •AF due to reversible cause e.g. hyperthyroid state
  • •Women who are pregnant or plan to become pregnant during the course of the trial** Note: Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomization.
  • •Participation in other clinical trials that will affect the objectives of this study
  • •History of non-compliance to medical therapy
  • •Inability or unwillingness to provide informed consent
  • •Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
  • •Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial

研究组 & 干预措施

Endocardial PVI

Active Comparator

Endocardial complete PVI

干预措施: Endocardial PVI (Device)

Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI

Experimental

Minimally invasive surgical hybrid ablation using the convergent approach plus LAA exclusion using the clip

干预措施: Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI (Device)

结局指标

主要结局

Atrial fibrillation > 30 secs

时间窗: At 1 year

Based on serial 7-day Holter recordings

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Steinberg

Collaborator

University of Rochester

研究点 (1)

Loading locations...

相似试验

Endocardial Vs Epicardial Ablation for Recurrent... | 临床试验