NCT07279207

PACE-AF: Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation

Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation (PACE-AF)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Ilya Lukin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PACE-AF is a prospective, observational patient registry designed to evaluate the impact of pacemaker algorithms on atrial fibrillation (AF) incidence, progression, and clinical outcomes in patients implanted with dual-chamber pacemakers. The registry aims to include 400-500 patients with longitudinal follow-up. Primary outcomes are progression to permanent AF and all-cause mortality. Secondary outcomes include quality of life, hospitalization, and cardiovascular events.

Detailed description

The PACE-AF registry is a prospective, observational study designed to systematically evaluate the influence of advanced pacemaker algorithms on atrial fibrillation (AF) development and progression. Algorithms of interest include atrial preventive pacing, atrial tachycardia termination, Antitachycardia Pacing (reactive ATP), and other vendor-specific features. The registry will consecutively enroll all patients receiving dual-chamber pacemakers at Tver State Medical University and associated clinical sites. Approximately 400-500 patients are planned for inclusion, with follow-up scheduled according to standard of care and device interrogation. Primary outcomes are progression to permanent AF and all-cause mortality. Secondary outcomes include hospitalization, cardiovascular events, and quality of life. In addition, predefined substudies will investigate the hemodynamic consequences of different pacing sites (apical right ventricular pacing, septal pacing, His bundle pacing, and left bundle branch pacing). Hemodynamic evaluation will be performed intraoperatively using echocardiography, invasive atrial pressure monitoring, and electroanatomical mapping techniques. Further exploratory analyses will assess outcomes in pacemaker patients who have undergone catheter ablation or cryoablation for AF. This registry represents a structured attempt to combine real-world data on pacemaker function with detailed hemodynamic and electrophysiological assessment, with the overarching aim of identifying strategies to prevent AF progression in this patient population.

Conditions

• Atrial Fibrillation
• Sick Sinus Syndrome
• Atrioventricular Block

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: Russia