Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) - IDE Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 153
- 试验地点
- 22
- 主要终点
- 12-month freedom from recurrent atrial fibrillation
研究概览
简要总结
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone.
The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.
详细描述
Patients with persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. After catheter ablation (isolation) of the pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all patients will be randomized to either PVI alone or the combination of PVI + posterior left atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be completed at that time. For those patients randomized to PVI + PWI, they will have additional ablation to achieve PWI.
All study patients will have the same follow-up after their ablation procedure, including clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the ablation. Blood thinners are recommended for two months after ablation and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the decision of the study doctor. Information about the patients' medical history, heart arrhythmias and atrial fibrillation will be collected during the study which will be analyzed.
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
- Double (Participant, Investigator)
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
- •Consistent with the current definitions, all patients with Persistent AF must exhibit an episode of continuous AF that is sustained >7 days.
- •Patients must have symptomatic Persistent AF refractory or intolerant to at least one class I or class III antiarrhythmic drug
- •Males and females with an age >18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted
- •All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
- •Patients must have documented episode of AF greater than 7 days in the year prior to the procedure
排除标准
- •History of long-standing persistent AF
- •Any reversible cause of AF (post-operative, thyroid disorder, etc.)
- •Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
- •Patients with any corrected or uncorrected congenital heart disease
- •Patients with a history of hypertrophic cardiomyopathy
- •Patients with cardiomyopathy and a left ventricular ejection fraction <40%
- •Congestive heart failure, class IV
- •Left atrial (LA) diameter >55 mm (parasternal long axis view)
- •Patients with left atrial thrombus
- •Women who are known to be pregnant or have had a positive β-HCG (human chorionic gonadotropin) test 7 days prior to procedure
- •Patients whose life expectancy is <1 year
- •History of left-sided left atrial ablation (catheter or surgically-based)
- •Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
结局指标
主要结局
12-month freedom from recurrent atrial fibrillation
时间窗: 12 months
Number of participants with recurrent atrial fibrillation following catheter ablation
次要结局
- All atrial arrhythmia recurrences(During a follow-up period of 12 months)
- Freedom from cardioversion for recurrent atrial arrhythmias(During a follow-up period of 12 months)
- Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)(During a follow-up period of 12 months)
- Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence(During a follow-up period of 12 months)
- New York Heart Association Functional Class as predictor of atrial fibrillation recurrence(During a follow-up period of 12 months)
- Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)(During a follow-up period of 12 months)
- Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence(During a follow-up period of 12 months)
- Multiple procedure success(During a follow-up period of 12 months)
- Relative reduction in atrial fibrillation burden(During a follow-up period of 12 months)
- Freedom from repeat atrial fibrillation ablation(During a follow-up period of 12 months)
研究者
Arash Aryana, MD
Principal Investigator
Dignity Health Medical Foundation