Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,742
- 试验地点
- 2
- 主要终点
- Clinical Composite Score
研究概览
简要总结
This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.
详细描述
PEGASUS CRT is a multicenter trial that will assess the effect of a cardiac resynchronization therapy defibrillator (CRT-D) device programmed to DDD-70 or DDDR-40 compared to a CRT device programmed to DDD-40 in heart failure patients. The effect of atrial support pacing in heart failure patients will be assessed using a clinical composite rating. A sub-study will evaluate the effect pacing mode has on exercise capacity in this heart failure population.
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
- •Patients who meet current indications for the CONTAK RENEWAL® family of cardiac resynchronization therapy defibrillator (CRT-D) devices or future Food and Drug Administration (FDA) approved Guidant CRT-D devices
- •Patients who sign and date a Patient Informed Consent at, or prior to, the implant visit
- •Patients who are in sinus rhythm at the time of implant
- •Patients who remain in the clinical care of the enrolling physician in approved centers
- •Patients who are on optimal pharmacologic therapy or who have developed a recent implantable cardioverter defibrillator (ICD) indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy
排除标准
- •Patients whose medical condition is expected to preclude the use of the protocol-required pacing mode (dual chamber pacing [DDD or DDDR]) and respective lower rate limits
- •Patients with permanent atrial fibrillation or atrial flutter
- •Patients who are in complete heart block
- •Patients who have previously had a pacemaker, ICD, or CRT device
- •Patients whose life expectancy is less than 12 months due to other medical conditions
- •Patients who are expected to receive a heart transplant during the duration of the study
- •Patients who have other cardiac surgeries or procedures planned but not yet performed
- •Patients who currently have or who are likely to receive a tricuspid valve prosthesis
- •Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study.
- •Patients who are younger than 18 years of age
- •Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
- •Patients who are or become pregnant
结局指标
主要结局
Clinical Composite Score
时间窗: From randomization (6-weeks) through 12-month visit
The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association \[NYHA\] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.
次要结局
- Change in Quality of Life(From randomization (6-weeks) through 12-month visit)
- Change in Self Assessed Physical Activity(From randomization (6-weeks) through 12-month visit)