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

Ilya Lukin

Status: Not yet enrolling

Conditions: Atrioventricular Block; Atrial Fibrillation; Sick Sinus Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT07279207

PACE-AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Age ≥ 18 years

  • Implantation of a dual-chamber permanent pacemaker
  • Ability to provide informed consent
  • Willingness to participate in long-term follow-up

Exclusion criteria

• • Single-chamber pacemaker or Cardiac Resynchronization Therapy device at baseline

  • Life expectancy < 1 year due to non-cardiac comorbidities
  • Inability to comply with follow-up visits or device interrogation
  • Participation in another clinical trial that could interfere with study endpoints