AimsAtrial fibrillation (AF) is common in heart failure (HF) and negatively impacts outcomes. The role of ablation‐based rhythm control in patients with AF and HF with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF) is not known. The CABA‐HFPEF‐DZHK27 (CAtheter‐Based Ablation of atrial fibrillation compared to conventional treatment in patients with Heart Failure with Preserved Ejection Fraction) trial will determine whether early catheter ablation for AF can prevent adverse cardiovascular outcomes in patients with HFpEF or HFmrEF.MethodsCABA‐HFPEF‐DZHK27 (NCT05508256) is an investigator‐initiated, prospective, randomized, open, interventional multicentre strategy trial with blinded outcome assessment. Approximately 1548 patients with paroxysmal or persistent AF diagnosed within 24 months prior to enrolment and HFpEF or HFmrEF will be randomized to early catheter ablation within 4 weeks after randomization or to usual care. All patients receive anticoagulation, rate control, and HF management according to current guideline recommendations. Usual care can include rhythm control in symptomatic patients. Patients will be followed until the end of the trial for the primary outcome, a composite of cardiovascular death, stroke, and total unplanned hospitalizations for HF or acute coronary syndrome. The safety outcome comprises complications of catheter ablation and death. The trial is powered for a rate ratio of 0.75 (two‐sided alpha = 0.05, 1‐beta = 0.8).ConclusionCABA‐HFPEF‐DZHK27 will define the role of systematic and early catheter ablation in patients with AF and HFpEF or HFmrEF.

中文翻译：

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基于导管的消融可改善射血分数保留的房颤和心力衰竭患者的预后：CABA-HFPEF-DZHK27 试验的基本原理和设计


目的心房颤动 (AF) 在心力衰竭 (HF) 中很常见，并对结果产生负面影响。基于消融的节律控制对于射血分数保留（HFpEF）或轻度降低（HFmrEF）的 AF 和 HF 患者的作用尚不清楚。 CABA-HFPEF-DZHK27（射血分数保留的心力衰竭患者中基于导管的房颤消融与常规治疗相比）试验将确定房颤的早期导管消融是否可以预防 HFpEF 或 HFmrEF 患者的不良心血管结局。 ‐HFPEF‐DZHK27 (NCT05508256) 是一项研究者发起的、前瞻性、随机、开放、介入性多中心策略试验，采用盲法结果评估。约 1548 名在入组前 24 个月内诊断为阵发性或持续性 AF 且患有 HFpEF 或 HFmrEF 的患者将在随机化后 4 周内随机接受早期导管消融或接受常规护理。所有患者均根据当前指南建议接受抗凝、心率控制和心力衰竭管理。常规护理包括对有症状的患者进行节律控制。将对患者进行随访直至试验结束，以了解主要结局，即心血管死亡、中风以及因心力衰竭或急性冠状动脉综合征而计划外住院的综合结果。安全性结果包括导管消融并发症和死亡。该试验的效率比为 0.75（双侧 α = 0.05，1-β = 0.8）。 结论 CABA-HFPEF-DZHK27 将明确系统性和早期导管消融在 AF 和 HFpEF 或 HFmrEF 患者中的作用。