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Patient Selection and Long-Term Outcomes of Pace & Ablate Strategy in Atrial Fibrillation

Study acronym: REPACE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Atrioventricular node ablation with permanent pacing (the "pace-and-ablate" strategy) controls ventricular rate in atrial fibrillation that has not responded to drug therapy or catheter ablation. Chronic right ventricular pacing, however, can cause pacing-induced cardiomyopathy (PICM), and it is not well established which patients are at risk and should therefore receive conduction system pacing or biventricular pacing instead. REPACE is a multicentre retrospective cohort of consecutive patients who underwent atrioventricular node ablation from January 2011 onwards at five centres in Switzerland, the United Kingdom and Poland: Liverpool Heart and Chest Hospital, Inselspital Bern, University Hospital Basel, Geneva University Hospitals and the Silesian Centre for Heart Diseases, Zabrze. More than 2,000 patients ablated up to March 2024 have been included to date; patients ablated after that date at the participating centres are being added. The study has three aims: to validate, in an independent multicentre population, a previously published risk model for pacing-induced cardiomyopathy; to describe the procedural technique and outcomes of atrioventricular node ablation across different health systems; and to estimate the health-economic impact of the pace-and-ablate strategy. Pacing-induced cardiomyopathy is defined as an absolute reduction in left ventricular ejection fraction of at least 10 percentage points to a value below 50%. All potential endpoints are adjudicated by a clinical events committee blinded to the classification made at the site.
Trial Details
NCT Number NCT07852221
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Collaborators: University of Bern, Liverpool Heart and Chest Hospital NHS Foundation Trust, University Hospital, Basel, Switzerland, University Hospital, Geneva, Silesian Centre for Heart Diseases, Zabrze
Conditions
(from sponsor)
Atrial Fibrillation (AF), Cardiomyopathy, Secondary, Pacing-Induced Cardiomyopathy, Heart Failure
Related terms Atrial Fibrillation, Cardiomyopathies, Heart Failure
Enrollment 2,600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov