Conduction System PACing and Atrioventricular Node Ablation in Patients With hEart Failure, Left Ventricular Ejection Fraction >40% and Permanent Atrial FIBrilation: the PACE-FIB Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Contact Information
Primary
Daniel Rodriguez Muñoz, MD, PhD
danielantonio.rodriguez@salud.madrid.org
+34 917792742
Backup
Ana Isabel Castillo Varón, PhD
aicastillo.imas12@h12o.es
+34 917792742
Time Frame
Start Date: 2022-04-29
Estimated Completion Date: 2030-09
Participants
Target number of participants: 334
Treatments
Experimental: Conduction System Pacing and AV node ablation
Atrioventricular node ablation and subsequent conduction system pacing
No_intervention: Medical treatment for rate control of AF
Pharmacological rate control based on clinical practice guidelines
Related Therapeutic Areas
Sponsors
Collaborators: Sociedad Castellana de Cardiologia
Leads: Daniel Rodríguez Muñoz

This content was sourced from clinicaltrials.gov