Resynchronization Therapy in Normal QRS (RethinQ) Clinical Investigation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 34
- 主要终点
- Cardiac resynchronization therapy (CRT) effectiveness will be evaluated in terms of exercise capacity (peak VO2), as measured by cardiopulmonary exercise testing
研究概览
简要总结
Patients with heart failure have a pumping action of the ventricles in which one ventricle contracts before the other ventricle. This uncoordinated (unsynchronized) pumping is due to a delay in the stimulation of the left ventricle because of its increased size. Pacing both the right and the left side of the heart (or cardiac resynchronization therapy [CRT]) has been proven to be effective in the treatment of heart failure (HF). Current market-approved devices combine both pacing (CRT) and shocking (implantable cardioverter defibrillator [ICD]) therapy for patients who have severe heart failure and are at risk for developing life-threatening heart rhythms. These devices provide an electrical pacing stimulus to both ventricles and may help the heart contract in a more coordinated way and improve heart failure symptoms.
The investigational portion of this trial involves the implantation of a market-approved CRT implantable cardioverter defibrillator (CRT-D) system in patients who do not meet the current criteria for a CRT implant. In order to receive a CRT-D implant today, patients must have heart failure symptoms, have a weakened heart muscle, and have uncoordinated pumping of the heart. To demonstrate this uncoordinated pumping of the heart, a test (electrocardiogram [ECG]) is done. It is believed that by using a different test (echocardiogram) to measure whether this uncoordinated pumping is present, more patients will be identified that will benefit from CRT-D therapy. This study will look at whether patients identified by using this echocardiogram test show a benefit from having this CRT-D therapy.
详细描述
1.0 Problem of Interest
Patients with heart failure have a pumping action of the ventricles in which one ventricle contracts before the other ventricle. This uncoordinated (unsynchronized) pumping is due to a delay in the stimulation of the left ventricle because of its increased size. Pacing both the right and the left side of the heart (or cardiac resynchronization therapy [CRT]) has been proven to be effective in the treatment of heart failure. Current market-approved devices combine both pacing (CRT) and shocking (ICD) therapy for patients who have severe heart failure and are at risk for developing life-threatening heart rhythms. These devices provide an electrical pacing stimulus to both ventricles at the same time and may help the heart contract in a more coordinated way and improve heart failure symptoms.
The investigational portion of this trial involves the implantation of a market-approved CRT implantable cardioverter defibrillator (CRT-D) system in patients who do not meet the current criteria for a CRT implant. In order to receive a CRT-D implant today, patients must have heart failure symptoms, have a weakened heart muscle, and have uncoordinated pumping of the heart. To demonstrate this uncoordinated pumping of the heart, a test (ECG) is done. It is believed that by using a different test (echocardiogram) to measure whether this uncoordinated pumping is present, more patients will be identified that will benefit from CRT-D therapy.
2.0 Study Summary
Testing will be performed to determine if patients are eligible for this study. An EKG (electrical tracing of the heart) will be performed. They will be asked to complete a 6- minute hall walk test that will provide information regarding their ability to exercise and conduct daily activities. An echocardiogram with tissue Doppler imaging (ultrasound of the heart) will be performed to determine how the heart muscle contracts. Results of this echocardiogram will determine if patients are eligible to participate in this 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
- Double
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
- •Have an approved indication for implantation of an ICD.
- •Have advanced HF with a New York Heart Association (NYHA) Classification of III, despite receiving optimal pharmacological therapy.
- •Have a stable heart failure medical regimen.
- •Have a left ventricular ejection fraction (LVEF) <= 35%.
- •Have evidence of mechanical dyssynchrony as measured by echocardiography using tissue Doppler imaging or M-mode.
- •Have a QRS duration < 130 ms (present in all ECG leads).
- •Have the ability to complete exercise stress testing and 6-minute hall walk test, with the only limiting factors being related to cardiac fitness.
- •Have the ability to independently comprehend and complete a quality of life questionnaire.
- •Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
排除标准
- •Have a standard bradycardic indication for pacing.
- •Have been previously treated with CRT.
- •Have continuous atrial fibrillation [AF] (continuous is defined as AF lasting > 1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month.
- •Have the ability to walk > 450 meters during the 6-minute walk test.
- •Have a NYHA Classification of I, II or IV.
- •Have symptomatic chronic obstructive pulmonary disease (COPD) as it relates to exercise ability.
- •Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 6 months.
- •Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty [PTCA] or coronary artery bypass graft [CABG]) within 40 days of enrollment.
- •Have had a recent cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment.
- •Have severe musculoskeletal disorder(s).
- •Pregnant or planning for pregnancy in the next 6 months.
- •Currently participating in, or have participated in any clinical investigation within the last 30 days (the only exception being that of a registry trial).
- •Have a life expectancy of less than 6 months.
- •Less than 18 years of age.
结局指标
主要结局
Cardiac resynchronization therapy (CRT) effectiveness will be evaluated in terms of exercise capacity (peak VO2), as measured by cardiopulmonary exercise testing
时间窗: 6 months
Safety will be evaluated in terms of survival from CRT-D system-related complications.
时间窗: 6 months
次要结局
- New York Heart Association (NYHA) Classification(6 months)
- Quality of Life Questionnaire(6 months)