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首页> 外文期刊>Trials >Comparison of the rhythm control treatment strategy versus the rate control strategy in patients with permanent or long-standing persistent atrial fibrillation and heart failure treated with cardiac resynchronization therapy - a pilot study of Cardiac Resynchronization in Atrial Fibrillation Trial (Pilot-CRAfT): study protocol for a randomized controlled trial
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Comparison of the rhythm control treatment strategy versus the rate control strategy in patients with permanent or long-standing persistent atrial fibrillation and heart failure treated with cardiac resynchronization therapy - a pilot study of Cardiac Resynchronization in Atrial Fibrillation Trial (Pilot-CRAfT): study protocol for a randomized controlled trial

机译：永久性或长期性持续性心房颤动和心力衰竭患者接受心脏再同步治疗的心律控制治疗策略与心率控制策略的比较-心房颤动试验中心脏再同步的先导研究（Pilot-CRAfT）：研究方案用于随机对照试验

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Background The only subgroups of patients with heart failure and atrial fibrillation in which the efficacy of cardiac resynchronization therapy has been scientifically proven are patients with indications for right ventricular pacing and patients after atrioventricular junction ablation. However it is unlikely that atrioventricular junction ablation would be a standard procedure in the majority of the heart failure patients with cardiac resynchronization therapy and concomitant atrial fibrillation due to the irreversible character of the procedure and a spontaneous sinus rhythm resumption that occurs in about 10% of these patients. Methods/Design Pilot-CRAfT is the first randomized controlled trial evaluating the efficacy of a rhythm control strategy in atrial fibrillation patients with cardiac resynchronization therapy devices. The aim of this prospective, single center randomized controlled pilot study is to answer the question whether the patients with cardiac resynchronization therapy and permanent atrial fibrillation would benefit from a strategy to restore and maintain sinus rhythm (that is ‘rhythm control’ strategy) in comparison to rate control strategy. The study population consists of 60 patients with heart failure and concomitant long-standing persistent or permanent atrial fibrillation who underwent a cardiac resynchronization therapy device implantation at least 3 months before qualification. Study participants are randomly assigned to the rhythm control strategy (including electrical cardioversion and pharmacotherapy) or to the rate control group whose goal is to control ventricular rate. The follow-up time is 12 months. The primary endpoint is the ratio of effectively captured biventricular beats. The secondary endpoints include peak oxygen consumption, six-minute walk test distance, heart failure symptom escalation, reverse remodelling of the heart on echo and quality of life. Trial registration NCT01850277 registered on 22 April 2013 (ClinicalTrails.gov)
机译：背景技术心律失常和心房颤动的唯一亚组已被科学证明了心脏再同步治疗的功效，其中有右心室起搏适应症的患者和房室结消融后的患者。然而，由于该过程的不可逆性和大约10％的患者会自发恢复窦性心律，因此在大多数接受心脏再同步治疗并伴有心房纤颤的心力衰竭患者中，房室连接消融不太可能成为标准手术这些病人。方法/设计Pilot-CRAfT是第一个评估心律再同步治疗设备对房颤患者节律控制策略有效性的随机对照试验。这项前瞻性，单中心随机对照试验研究的目的是回答以下问题：相比之下，接受心脏再同步治疗和永久性房颤的患者是否将从恢复和维持窦性心律的策略（即“心律控制”策略）中受益评分控制策略。研究人群包括60例心力衰竭并伴有长期持续性或永久性心房颤动的患者，这些患者至少在合格前3个月接受了心脏再同步治疗设备植入。研究参与者被随机分配到心律控制策略（包括电复律和药物治疗）或目标是控制心室率的心率控制组。随访时间为12个月。主要终点是有效捕获的双心室搏动的比率。次要终点包括峰值耗氧量，六分钟步行测试距离，心力衰竭症状升级，心脏在回声和生活质量方面的逆向重塑。 2013年4月22日注册了NCT01850277试用注册（ClinicalTrails.gov）

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