Resynchronization for Ambulatory Heart Failure Trial in Patients With Chronic Atrial Fibrillation - Pharmacological Rate Control vs. Pace and Ablate With Conduction System Pacing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Habib Khan
- 入组人数
- 600
- 试验地点
- 12
- 主要终点
- Winratio
研究概览
简要总结
Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.
A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.
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 (Outcomes Assessor)
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 with permanent AF/persistent AF (in AF)
- •Patients with NYHA Class II -IVa HF symptoms
- •Guideline driven medical therapy (GDMT) for HF for at least 3 months:
- •for those < 75 years of age with an NT-proBNP of ≥ 600 ng/L
- •for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year
排除标准
- •In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
- •Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
- •Acute coronary syndrome <4 weeks or coronary revascularization <3months
- •Unable or unwilling to provide informed consent
- •Uncorrected primary valvular disease or prosthetic tricuspid valve
- •Restrictive, hypertrophic, or irreversible form of cardiomyopathy
- •Severe pulmonary diseases requiring oxygenation
- •Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis or drug-associated PH as well as those with high suspicion of irreversible pulmonary hypertension
- •Patients enrolled in competitive clinical trials that will affect the objectives of this study
- •Existing CRT/BiVP
- •Patients who are pregnant
- •Guideline indication for CRT
- •More than 20% pacing with an existing pacemaker
- •Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)
研究组 & 干预措施
Pharmacological Therapy
Patients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35%
干预措施: Medication (Drug)
P&A-CSP
Patients randomized to P&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks.
干预措施: Pace and Ablate (Device)
结局指标
主要结局
Winratio
时间窗: 12 months
Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, improvement in NT-proBNP and improvement in QOL.
次要结局
- All-cause mortality(12 months)
- Cardiovascular mortality(12 months)
- Number of heart failure events(12 months)
- All-cause hospitalization(12 months)
- Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ)(6 months)
- Exercise(6 months)
- Biochemical marker(6 months)
- Cognitive assessment(12 months)
研究者
Habib Khan
Cardiologist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's