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

NCT ID: NCT07279207

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ilya Lukin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilya B. Lukin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Tver State Medical University Clinical Center

Tver', Tver Oblast, Russia

Countries

Russia

Central Contacts

Ilya B. Lukin, MD, PhD

Role: CONTACT

prlukin@gmail.com

+7 906 656 2630

Facility Contacts

Ilya B. Lukin, MD, PhD

Role: primary

prlukin@gmail.com

+79066562630

References

Lukin I.B., Federiakin D.V., Gridiakina D.I., Karaagach M.H. The effect of atrial pacing on the risk of atrial tachyarrhythmias in patients with dual-chamber cardiac pacemakers: a pilot study. Journal of Arrhythmology. 2025;32(3):45-50. (In Russ.) https://doi.org/10.35336/VA-1509

Reference Type: BACKGROUND

Related Links

http://orcid.org/0000-0003-1871-2754

Author Open Researcher and Contributor ID (ORCID Profile) (Ilya B. Lukin)

http://doi.org/10.35336/VA-1509

Pilot study on atrial pacing algorithms and atrial fibrillation (Lukin et al., 2025)

Other Identifiers

PACE-AF

Identifier Type: -

Identifier Source: org_study_id