Efficacy and Safety Study of Adjunctive Ganglionated Plexus Ablation in Patients With Persistent Atrial Fibrillation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Left Atrial Dimensions
研究概览
简要总结
This study aims to investigate the long-term efficacy and safety of incorporating ganglionated plexus ablation into radiofrequency ablation strategies for persistent atrial fibrillation.
详细描述
- Study Design:
The study employs a parallel-group design with a 1:1 randomization ratio. Eligible patients meeting the specified criteria will be randomly assigned to either the conventional ablation group (pulmonary vein isolation + linear ablation) or the intervention group receiving additional ganglionated plexus ablation. 2. Intervention:
Control Group: Conventional ablation (pulmonary vein isolation + linear ablation) Intervention Group: Conventional ablation + ganglionated plexus ablation (left superior, left inferior, right anterior, and right inferior ganglionated plexi) 3. Randomization and Sequence Generation:
To ensure randomness and comparability, a computer-generated random sequence will be utilized. Specific steps include:
- Pre-matching the numbers 1-50 with 50 random numbers.
- Allocating each random number equally to 2 groups, with the assigned numbers representing the order of patient enrollment.
- Performing the above steps using R.
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)
盲法说明
This study employs a single-blind design, where the research staff is aware of the patient's group assignment, but the patients themselves are unaware of their group allocation. This approach is implemented to minimize potential subjective bias. The research staff will make efforts to maintain blinding during interactions with the patients to ensure objectivity in data collection and outcome assessment.
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 between 18 and 80 years, regardless of gender.
- •Patients confirmed by electrocardiogram or clinically diagnosed with persistent atrial fibrillation.
- •Individuals scheduled to undergo atrial fibrillation catheter ablation.
- •Willing to participate in the study and voluntarily sign the informed consent form.
排除标准
- •Patients with a history of prior atrial fibrillation ablation surgery.
- •Left ventricular ejection fraction (LVEF) less than 35%.
- •Left atrial anterior-posterior diameter greater than 50mm on echocardiography.
- •Presence of contraindications for atrial fibrillation ablation, such as the presence of clear thrombus in the left atrium detected preoperatively.
- •Patients with second-degree (Type II) or third-degree atrioventricular block.
- •Individuals with significant congenital heart defects (such as atrial septal defects or severe pulmonary vein stenosis, excluding unclosed foramen ovale).
- •Patients with implanted artificial valves.
- •Diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, or myxoma.
- •Untreated or uncontrolled hyperthyroidism or hypothyroidism.
- •Patients with active systemic infections.
- •Individuals with a significant bleeding tendency or those undergoing active blood dialysis due to renal failure.
- •Patients who have experienced myocardial infarction within the last 3 months or undergone any cardiac intervention/open-heart surgery.
- •Presence of clear contraindications for interventional procedures, as determined by the investigator.
- •Pregnant or lactating women, or those planning pregnancy during the study period.
- •Participation in other drug or medical device clinical trials within the last 3 months.
- •Patients deemed unsuitable for participation in this clinical trial by the investigator.
结局指标
主要结局
Left Atrial Dimensions
时间窗: 1 to 365 days post-catheter ablation.
Measurement of left atrial size, a key indicator of atrial remodeling, assessed as a primary outcome to evaluate the impact of the intervention on atrial structure.
Recurrence of Atrial Tachycardia and Time to Recurrence
时间窗: 91 to 365 days post-catheter ablation.
The first occurrence of sustained atrial arrhythmias (excluding atrial premature beats) lasting ≥30 seconds recorded between 91 to 365 days post-catheter ablation, including atrial fibrillation and atrial flutter, etc.
Left Ventricular Ejection Fraction, LVEF
时间窗: 1 to 365 days post-catheter ablation.
Assessment of left ventricular ejection fraction as a primary outcome measure, providing crucial insights into post-intervention cardiac function and guiding the evaluation of the treatment's efficacy on overall heart performance.
Procedure-Related Adverse Events
时间窗: 1 to 365 days post-catheter ablation.
Occurrence of adverse events related to the procedure during the perioperative or follow-up period, including but not limited to death, myocardial infarction, cardiac tamponade, and stroke.
次要结局
- Atrial Fibrillation Burden(91 to 365 days post-catheter ablation.)
- Patient's Postoperative Quality of Life(1 to 365 days post-catheter ablation.)
- Costs of treatment(From patient admission to discharge, averaging a duration of 3 days.)
- Radiofrequency Ablation Time(Recorded during the catheter ablation procedure.)
研究者
Ning Zhou
Professor
Tongji Hospital