Post Marketing Study on Heart Rate Regularization in Patients With Permanent Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 24
- 主要终点
- Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)
研究概览
简要总结
The purpose of this study is to monitor heart rate regularization in patients with permanent atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).
详细描述
The RARE PEARL is a multicenter prospective, randomized, double-blinded, crossover study.
Prior entering the study the patient should be informed and should give his written consent. Besides he/she should meet all selection criteria. The Investigator has to check that all selection criteria are satisfied. Then the patient undergoes pacemaker implantation, receiving a pacemaker model C20 SSIR or T20 SSIR (or later). The ventricular lead must be bipolar independently of the manufacturer.
After pacemaker implantation, a 45 days Stabilization Period is necessary to stabilize leads and drug therapy.
At the end of the stabilization period the patient is randomized to have VRS algorithm switched either ON or OFF. The 1° Study Phase ends after 2 months. Then a cross-over takes place: VRS algorithm is switched respectively OFF or ON and the 2° Study Phase is started. Also the 2° Study Phase ends after 2 months.
The randomization will be centralized: randomization lists will be generated and managed by the sponsor. Because the patients will undergo a QoL questionnaire at each crossover phase, they will have to be blinded about the status of their VRS setting. Similarly, also the co-investigators administering the QoL questionnaires have to be blinded about the status of VRS setting. Only the principal investigator knows if the VRS algorithm is ON or OFF. The principal investigator will be instructed not to inform the patient and the co-investigators administering QoL questionnaire about the setting until after the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Patient has signed informed consent form
- •Patient with permanent atrial fibrillation, standard indication for VVI(R) pacing, and at least 1 episode of rate irregularity in the last month
- •New York Heart Association (NYHA) Class I, II, III
- •Patient is able to comply with follow-up times and will comply with the protocol
- •> 18 years of age
排除标准
- •Paroxysmal atrial fibrillation
- •NYHA Class IV
- •Left ventricular ejection fraction (LVEF) < 35
- •Patients with unstable angina
- •Patients who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG), or coronary angioplasty (PTCA) within 3 months prior to enrolment
- •Patient candidate for cardiac surgery, or coronary angioplasty (PTCA)
- •Patients who experienced a cardiovascular accident (CVA) or transient ischemic attack (TIA) with permanent disability
- •Life expectancy < 12 months due to other medical conditions
- •Pregnancy
- •The patient is enrolled in any concurrent (drug and/or device) study
结局指标
主要结局
Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)
时间窗: June 2009
Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.
次要结局
- Evaluation of Rate Irregularity Indicators and Patient's Symptoms(January 2009)
- Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation(January 2009)
- Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate(January 2009)
- Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization(January 2009)