Heart Rate Regularization in Atrial Fibrilation and Heart Failure

NCT05029570 | Recruiting DMC

• 1 other identifier: PACE-FIB
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure; Atrial Fibrillation

Keywords

atrial fibrillation;; heart failure;; conduction system pacing;; heart rate regularization

Outcome Measures

Primary Outcomes (1)

• Composite primary endpoint

  All-cause mortality, heart failure hospitalisation and worsening heart failure

  36 months

Secondary Outcomes (11)

• All-cause mortality

  36 months

• Cardiovascular mortality

  36 months

• Heart failure hospitalization

  36 months

• Worsening heart failure

  36 months

• Unplanned cardiovascular hospitalisation

  36 months

Study Arms (2)

Conduction System Pacing and AV node ablation

EXPERIMENTAL

Atrioventricular node ablation and subsequent conduction system pacing

Device: Conduction System Pacing (pacemaker implantation)

Medical treatment for rate control of AF

NO INTERVENTION

Pharmacological rate control based on clinical practice guidelines

Interventions

Conduction System Pacing (pacemaker implantation) DEVICE

Conduction System Pacing (pacemaker implantation) and Atrioventricular node ablation

Also known as: Atrioventricular node ablation

Conduction System Pacing and AV node ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent atrial fibrillation
• At least one episode of hospitalisation due to heart failure in the previous 12 months.
• Left ventricular ejection fraction \> 40%
• Average resting heart rate ≤ 110 beats per minute
• NT-proBNP ≥ 900 pg/ml in the 30 days prior to enrollment
• Age ≥ 18 years
• Capacity to understand the nature of the study, legal ability and willingness to give informed consent.

You may not qualify if:

• Severe frailty (Clinical Frailty Scale ≥ 7) or comorbidity reducing life expectancy to \< 12 months.
• Acute heart failure at the time of enrollment or systolic blood pressure \< 80 mmHg in the absence of inotropic agents.
• Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml/1,73 m2
• Severe mitral or aortic valvular heart disease
• Anaemia (Haemoglobin \< 10 g/dl)
• Morbid obesity (BMI ≥ 35)
• Severe Chronic Obstructive Pulmonary Disease (Gold ≥ 3)
• Presence of a different indication for pacing of implantable cardioverter-defibrillator (ICD)
• Obstructive hypertrophic cardiomyopathy
• Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)
• Simultaneous participation in a different trial

Sponsors & Collaborators

• Daniel Rodríguez Muñoz: lead
• Sociedad Castellana de Cardiologia: collaborator

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando Arribas Ynsaurriaga, MD, PhD

  Hospital Universitario 12 de Octubre

  STUDY CHAIR

Central Study Contacts

Daniel Rodriguez Muñoz, MD, PhD

CONTACT

+34 917792742; danielantonio.rodriguez@salud.madrid.org

Ana Isabel Castillo Varón, PhD

CONTACT

+34 917792742; aicastillo.imas12@h12o.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical outcomes will be adjudicated by the investigator and reviewed by the Clinical Events Committee, that will be blind to treatment received by the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Cardiac Electrophysiology, Principal Investigator

Model Details: Medical Device: Conduction System Pacing (pacemaker implantation)

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 31, 2021
• Study Start: April 29, 2022
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)