A Prospective Multi-center Randomized Controlled Trial to Assess the Safety and Efficacy of One vs. Two Cryoablations Per Pulmonary Vein for the Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Composite Score of Adverse Events
研究概览
简要总结
The One Freeze study is a prospective multi-center randomized controlled trial to assess the safety and efficacy of one vs. two cryoablations per pulmonary vein for the treatment of atrial fibrillation.
详细描述
The One Freeze Trial is an investigator-initiated trial that has been developed by the Principals at the University of California, San Francisco (UCSF) and with full participation of the Steering Committee. One Freezel is a prospective multicenter randomized controlled trial with a goal to enroll and randomize a minimum of 90 study participants. Participants will be randomized in a 1:1 ratio to either PVI with a single freeze per pulmonary vein (1F Group) or to PVI with at least two freezes per pulmonary vein (2F Group). The One Freeze study's primary aim is to determine if one 3-minute cryoablation per pulmonary vein results in a lower composite adverse event score as compared to the traditional method of using two 3-minute cryoablations per pulmonary vein.
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
- 否
入选标准
- •Paroxysmal atrial fibrillation
- •Age ≥ 18 years
- •Life expectancy ≥ 1 year
- •Willing and able to return to and comply with scheduled follow-up visits
- •Willing and able to provide written informed consent
排除标准
- •History of > 5 electric cardioversions
- •History of previous pulmonary vein isolation ablation for atrial fibrillation
- •History of MAZE procedure
- •Left ventricular EF ≤ 35% within the past 12 months
- •Mechanical mitral valve
- •Single PV > 30 mm in diameter, unless deemed appropriate by the site PI
- •Stroke/TIA within the past 6 months
- •Creatinine > 2.0 mg/dL within the past 6 months
- •Pregnancy or desire to get pregnant within the next 12 months
- •Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study
- •Mental impairment or other conditions, which may not allow the participant to understand the nature, significance and scope of the study
- •Any other condition or circumstance that in the judgment of the Clinical Site Investigator that makes the participant unsuitable for the study
结局指标
主要结局
Composite Score of Adverse Events
时间窗: 12 months
Composite score of adverse events (Range 0-20 points) will be calculated after the patient has completed follow-up. Higher scores indicate greater severity. Luminal Esophageal Temperature (LET) (0-2 points): 1-point if ≤20 degrees C, 2-points if ≤15 degrees C Phrenic nerve injury (0-3 points): 1-point if ≥30% decrease in compound muscle action potential (CMAP) or loss of phrenic nerve capture resulting in cessation of freeze (without movement of pacing catheter), 2-points if Phrenic nerve palsy lasting\> 1 minute resolving on table, 3-points if Phrenic nerve palsy not resolving on the table Pulmonary (0-4 points): 1-point if persistent dry cough \> 1 week post ablation, 4-points if Hemoptysis Gastrointestinal (GI) (0-6 points): 1-point if Gastroparesis symptoms, 3-points if Esophageal ulceration, 6-points if left atrial-esophageal fistula Pulmonary vein (PV) stenosis (0-5 points): 1-point if ≥50% luminal area, 4-points if ≥90% luminal area, 5-points if total occlusion
次要结局
- Participants free from symptomatic atrial fibrillation (AF)(6 months and 12 months)
- Atrial Fibrillation (AF) burden(6 months, 12 months)
- Procedure Time(4 - 8 hours)
- Left Atrial Access time(4 - 8 hours)
- Fluoroscopy Time(4 - 8 hours)
- Number of cryoablations needed to isolate each vein(4 - 8 hours)
- Acute success of the Pulmonary Vein Isolation (PVI)(4 - 8 hours)
- Individual Adverse Events(within 12 months after the Pulmonary Vein Isolation (PVI))
- Number of re-isolations required(4 - 8 hours)