Pacing and AV Node Ablation Compared to Drug Therapy in Symptomatic Elderly Patients With Atrial Fibrillation Clinical Trial (PACIFIC) - Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- Cardiac Hospitalization Within Six Months of Enrollment
研究概览
简要总结
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF).
详细描述
Epidemiologic studies have shown that 70-80% of patients with atrial fibrillation are older than 65 years of age. Drug therapy for atrial fibrillation is not effective or not tolerated in many elderly patients, for both rate or rhythm strategies. Preliminary data from AVN ablation and pacemaker therapy demonstrated this strategy is highly effective in controlling symptoms among patients who have failed numerous drug therapy. Quality of life is improved while hospital admission and office visits are reduced.
Pilot Study Design
- All patients will be 1:1 randomized to standard-care drug therapy (American College of Cardiology/American Heart Association Guideline, 2006) or AV node ablation and pacemaker therapy
- For patients randomized to AVN ablation, there will be a 1:1 sub-randomization to conventional right ventricular apex pacing or cardiac resynchronization therapy (biventricular pacing)
- All patients will be followed at 2 and 6 months from the time of randomization in the pilot study.
- A total of 60 patients from 5-15 clinical sites will be enrolled during an active recruiting period of 12 months for the pilot study.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 65 years
- •Paroxysmal, persistent, or permanent atrial fibrillation
- •Index event of atrial fibrillation is documented on electrocardiogram or rhythm strip. Atrial fibrillation must be the qualifying event. Atrial flutter can have been present in the past, but it must not be considered the index arrhythmia.
- •Paroxysmal atrial fibrillation episodes must be recurrent (two or more episodes in the past 6 months). At least one of the paroxysmal episodes must be "sustained", defined as lasting greater than 1 hour documented by a Holter monitor or by history in conjunction with an ECG or a rhythm strip.
- •At least one attempt of unsuccessful drug therapy, either for rate, for rhythm, or for rate-and-rhythm control.
- •Symptoms related to atrial fibrillation within the last 6 months
- •Eligible for long-term treatment with both treatment strategies
- •Must provide informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and be willing to comply with follow-up requirements.
排除标准
- •Reversible causes of atrial fibrillation
- •On heart transplant list
- •Familial cardiac conditions with increased risk of sudden death
- •Asymptomatic
- •Medical condition limiting expected survival to be less than one year
- •Contraindications to anticoagulation
- •Pre-existing implanted pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device.
- •Pre-existing indication for permanent pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device
- •More than one attempt of drug therapy for rate, for rhythm, or for rate-and-rhythm control
- •Planned major surgery within the next six months, including thoracic surgery
- •Disability that would preclude collection of study data or have co-morbidity that would contraindicate device implantation
- •Participated in another clinical trial within the previous 30 days using a therapeutic modality which could have potential residual effects that might confound the results of this pilot study
- •Unable to provide informed consent
研究组 & 干预措施
Drug Therapy
FDA approved rate and rhythm control drugs
干预措施: FDA approved rate and rhythm control drugs (Drug)
Atrioventricular Node (AVN) Ablation / Pacing
AV Node ablation and device implant
干预措施: AV Node ablation and device implant (Device)
结局指标
主要结局
Cardiac Hospitalization Within Six Months of Enrollment
时间窗: Six months after enrollment
Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.
次要结局
未报告次要终点