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RECRUITING
NCT07852221

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

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

Summary

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.

Official title: Patient Selection and Long-Term Outcomes in Patients With a Pace & Ablate Strategy for Interventional Rate Control in Symptomatic Permanent Atrial Fibrillation - A Retrospective Multicenter Analysis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2600

Start Date

2011-01-05

Completion Date

2027-12-31

Last Updated

2026-10-01

Healthy Volunteers

No

Locations (5)

Silesian Centre for Heart Diseases

Zabrze, Poland

Inselspital, Universitätsspital Bern

Bern, Canton of Bern, Switzerland

University Hospital Basel

Basel, Switzerland

Geneva University Hospitals

Geneva, Switzerland

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, United Kingdom