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Heart Rate Regularization in Atrial Fibrilation and Heart Failure

NCT05029570 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2025-09-09

No results posted yet for this study

Summary

The PACE-FIB trial is a multicentre, randomised, open-label clinical trial. Patients older than 18 years, with permanent AF, LVEF\>40%, average resting heart rate ≤ 110 beats per minute (bpm), at least one hospitalisation due to HF in the previous year and basal NT-proBNP level\>900 pg/ml will be randomised to either CSP and subsequent AV node ablation (intervention group) vs. pharmacologic rate control optimised according to clinical practice guidelines. The impact of both strategies on a composite primary endpoint of all-cause mortality, HF hospitalisation and worsening HF will be evaluated during a 36-month follow-up.

Conditions

Interventions

DEVICE

Conduction System Pacing (pacemaker implantation)

Conduction System Pacing (pacemaker implantation) and Atrioventricular node ablation

Sponsors & Collaborators

  • Sociedad Castellana de Cardiologia

    collaborator OTHER

  • Daniel Rodríguez Muñoz

    lead OTHER

Principal Investigators

  • Fernando Arribas Ynsaurriaga, MD, PhD · Hospital Universitario 12 de Octubre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2030-07-31
Completion
2030-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05029570 on ClinicalTrials.gov