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Recruiting NCT06207383

Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure

Trial Parameters

Condition Atrial Fibrillation, Persistent
Sponsor University Hospital, Geneva
Study Type INTERVENTIONAL
Phase N/A
Enrollment 220
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2024-10-01
Completion 2028-06
Interventions
Conduction system pacingAtrioventricular nodal ablationAtrial fibrillation ablation

Brief Summary

The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation. The effect of treatment allocation on total mortality, cardiovascular hospitalization and heart failure hospitalization will be compared.

Eligibility Criteria

Inclusion Criteria: (i) Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure. (ii) At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP \> 1000 pg/ml or BNP \> 250 pg/ml measured at any timepoint during this interval. (iii) Previous or current rate or rhythm control drug therapy. (iv) Age \> 60 years Exclusion Criteria: (i) NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy. (ii) Life expectancy \< 2 years. (iii) Need for major surgical intervention. (iv) Myocardial infarction, stroke or PCI within the previous 3 months. (v) Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable. (vi) Participation in another controlled trial. (vii) Inability to sign and informed consent form.

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