Comparative Effectiveness of Different Techniques for Repeat Ablation After Failed Initial Ablation for Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS)
研究概览
简要总结
Atrial fibrillation (AF) is the most common type of irregular heartbeat doctors see. People with AF sometimes have a procedure called an ablation to help get their heart back into a normal rhythm. However, this treatment doesn't always work. This study is looking at whether adding an extra step to the usual ablation-specifically treating another area of the heart called the left atrial (LA) posterior wall-can help people feel better overall, compared to just repeating the standard pulmonary vein isolation ablation procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years on date of consent
- •One prior PVI ablation procedure > 3 months prior for persistent AF
- •Recurrent paroxysmal or persistent symptomatic AF confirmed on ECG despite prior PVI
- •Eligible for repeat ablation procedure
- •Willingness to comply with all 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)
- •Prior ablation that included non-PVI LA ablation, or more than one prior PVI ablation procedure for persistent AF
- •Prior surgical ablation for AF
- •Contraindication to systematic anticoagulation
- •LA diameter on echocardiogram > 6.0 cms
- •LV ejection fraction < 35%
- •NYHA class III-IV congestive heart failure
- •Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date
- •Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
- •Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
- •Prior valve replacement with mechanical prosthesis
- •Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date
- •Stroke within 3 calendar months prior to consent date
- •Any medical condition likely to limit survival to < 1 year
- •Renal failure requiring dialysis at time of consent
- •Pregnancy
- •History of non-compliance to medical therapy
- •Participation in other clinical trials (observational/lead registries are allowed) without approval from the CCRC
- •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
Repeat PVI with LA PWI
干预措施: Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI) (Procedure)
Repeat PVI without LA PWI
干预措施: Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI) (Procedure)
结局指标
主要结局
Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS)
时间窗: From Baseline to Month 12
The AFSS is a 19-item self-report instrument measuring atrial fibrillation burden. It includes symptom severity (7 items), frequency/duration (4 items), health care utilization (4 items), and a global well-being visual analog scale. Items are summed into a composite total burden score, ranging from 0 to 100, with higher scores indicating greater symptom burden and healthcare impact.
次要结局
- Time to First Atrial Fibrillation Episode Lasting > 30 Seconds(Up to 24 Months Following Randomization)
- Mean Total Atrial Fibrillation Burden from Serial Holter Recordings(From Randomization through Month 24)
- Mean Total Number of Cardiovascular Health Care Utilization Events(From Randomization through Month 48)
- Mean Total Number of Major Clinical Events(From Randomization through Month 48)
研究者
Jonathan Steinberg
Research Professor of Medicine
University of Rochester