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临床试验/NCT07405359
NCT07405359招募中不适用

A Randomized Trial of Pulmonary Vein Isolation Alone Versus Pulmonary Vein Isolation Plus Posterior Wall and Superior Vena Cava Isolation With Pulsed Field Ablation for Treatment of Persistent Atrial Fibrillation

Edward Gerstenfeld, MD1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2026年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
220
试验地点
1
主要终点
AF freedom

研究概览

简要总结

Catheter based ablation of atrial fibrillation (AF) is an established treatment modality for rhythm control of AF, with pulmonary vein isolation (PVI) being the cornerstone of this technique. While pulmonary vein triggers are the predominant arrhythmia mechanism in paroxysmal AF, development of additional atrial substrate contributes to maintenance of AF in persistent AF. This is likely to account for the lower rates of freedom from recurrent AF following ablation in patients with persistent AF. Various adjunctive empiric ablation strategies, such as left atrial posterior wall isolation (PWI), superior vena cava isolation (SVCI), linear ablation, and ablation of complex fractionated atrial electrograms have been studied to address this limitation of PVI alone.

While observational data supports the safety and feasibility of Posterior Wall Isolation (PWI) and Superior Vena Cava Isolation (SVCI) with PFA, the efficacy of these strategies with PFA has not been demonstrated in randomized controlled trials. Whether mapping prior to ablation (i.e. detecting scar) predicts if PW and SVC sites are effective in improving ablation outcome is unknown.

This study will test the hypothesis of whether empiric addition of PW and SVC isolation with PFA to PVI improves outcome (freedom from atrial tachyarrhythmia at 1-year). The investigators therefore propose a randomized controlled trial to compare the efficacy of Pulmonary Vein Isolation (PVI) alone versus PVI + PWI + SVCI in patients with persistent AF. The investigators hypothesize that the addition of PWI and SVCI to PVI in patients with persistent AF will provide improved freedom from AFIB off anti-arrhythmic drugs, without significantly increasing rates of procedural complications. Secondary analysis includes subgroups with posterior wall scar, procedure times, freedom from AFIB on or off anti arrhythmic drugs, etc.

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 (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years at their pre-procedure visit
  • Persistent AF, defined as at least one continuous AF episode lasting at least seven days in duration, documented by a continuous monitor or 2 ECGs>7 days apart or ≥3 cardioversions
  • Indicated and interested in ICM implant for monitoring post ablation
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

排除标准

  • Any prior atrial endocardial or epicardial ablation procedure, other than cavotricuspid isthmus ablation or supraventricular tachycardia
  • Stroke or transient ischemic attack within the previous six months
  • Gastrointestinal bleeding within the previous three months
  • Implanted pacemaker or defibrillator
  • Longstanding persistent AF (> 3 years)
  • LA volume >80ml/m2
  • Atrial septal occlusion device
  • Current left atrial thrombus
  • Left atrial appendage occlusion or closure device < 6 mos or with leak or prior DRT
  • Mitral or Tricuspid valve clip or mechanical replacement or clip
  • Hypertrophic cardiomyopathy
  • Contraindication to femoral vascular access
  • Congenital heart disease with residual anatomic abnormality
  • Contraindication to, or unwillingness to use, systemic anticoagulation
  • Pregnancy
  • Left ventricular ejection fraction <30%
  • Baseline creatinine >2.0 mg/dL
  • Predicted life expectancy less than one year
  • Refusal to receive ICM implant or allergy to ICM

研究组 & 干预措施

PVI alone

Active Comparator

Afib ablation: PVI only

干预措施: Implantable loop recorder (Procedure)

PVI alone

Active Comparator

Afib ablation: PVI only

干预措施: PFA (Device)

PVI + PWI + SVCI

Experimental

Afib ablation: PVI + PWI + SVCI

干预措施: AF Ablation: PVI + PWI + SVCI (Procedure)

PVI + PWI + SVCI

Experimental

Afib ablation: PVI + PWI + SVCI

干预措施: PFA (Device)

PVI + PWI + SVCI

Experimental

Afib ablation: PVI + PWI + SVCI

干预措施: Implantable loop recorder (Procedure)

结局指标

主要结局

AF freedom

时间窗: 12 months

First recurrence of AT/AFL/AF \> 1 hour after a 2-month blanking period Any 1) cardioversion 2) redo ablation or 3) escalation/change in AAD after the 2-month blanking period (allowing 3 months to stop AADs) is considered a failure of the primary endpoint

次要结局

未报告次要终点

研究者

发起方
Edward Gerstenfeld, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Edward Gerstenfeld, MD

Professor, Medicine

University of California, San Francisco

研究点 (1)

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