Rate or Rhythm Control in CRT (RHYTHMIC): Study rationale and protocol.

Abstract

Atrial fibrillation (AF) has several detrimental effects on heart failure patients treated with cardiac resynchronization therapy (CRT). These include suboptimal biventricular pacing and the loss of atrioventricular (AV) synchrony. AV node ablation improves biventricular pacing and clinical outcomes in large observational studies. However, restoration of sinus rhythm with AF ablation may have additional benefits. To compare the effects of AV node ablation and AF ablation on echocardiographic and symptomatic outcomes in patients with CRT and suboptimal biventricular pacing. RHYTHMIC is a multicenter prospective randomized controlled trial. Seventy patients will be recruited and randomized to each ablation strategy in a 1:1 ratio. Key inclusion criteria include a previous CRT implant (with atrial lead) for dyssynchronous heart failure, and biventricular pacing <95% secondary to AF. Patients with permanent AF will be excluded. Patients will undergo baseline assessment including transthoracic echocardiography (TTE), device check, blood tests, electrocardiogram (ECG), 6-minute walk test, and symptom questionnaire. They will then undergo either AV node ablation or AF ablation according to their allocated group. Follow-up will occur at 1 week (TTE and ECG) and at 6 months (repeat of baseline investigations). The primary endpoint will be change in left ventricular ejection fraction on TTE. This is the first randomized controlled trial comparing AV node ablation and AF ablation in patients with CRT. We anticipate it will provide valuable insight into the management of this frequently encountered clinical scenario in a challenging patient cohort.