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

NCT07279207 | Not Yet Recruiting

• 1 other identifier: PACE-AF
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Sick Sinus Syndrome; Atrioventricular Block

Keywords

Pacemaker; Dual-chamber pacing; Pacemaker algorithms; Conduction system pacing; His bundle pacing; Left bundle branch pacing; Catheter ablation; Cryoablation; Arrhythmia prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of Permanent Atrial Fibrillation (%)

  Transition from paroxysmal or persistent atrial fibrillation to permanent atrial fibrillation, defined as a clinical decision to cease rhythm control strategies and accept permanent AF

  Up to 3 years of follow-up

Secondary Outcomes (4)

• All-Cause Mortality Rate (number of participants)

  Up to 3 years

• AF Burden (% of time in atrial fibrillation)

  Up to 3 years

• Mean Left Atrial Pressure During Pacing (mmHg)

  Baseline intraoperative

• Change in Left Atrial Volume Index (mL/m²)

  Baseline intraoperative + up to 12 months follow-up

Eligibility Criteria

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

Study Population

Consecutive adult patients undergoing implantation of dual-chamber pacemakers at Tver State Medical University and affiliated hospitals.

You may qualify if:

• Age ≥ 18 years
• Implantation of a dual-chamber permanent pacemaker
• Ability to provide informed consent
• Willingness to participate in long-term follow-up

You may not qualify if:

• 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

Sponsors & Collaborators

• Ilya Lukin: lead

Study Sites (1)

Tver State Medical University Clinical Center

Tver', Tver Oblast, 170000, Russia

Location

Related Publications (1)

• 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

  BACKGROUND

Related Links

• Author Open Researcher and Contributor ID (ORCID Profile) (Ilya B. Lukin)
• Pilot study on atrial pacing algorithms and atrial fibrillation (Lukin et al., 2025)

MeSH Terms

Conditions

Atrial Fibrillation; Sick Sinus Syndrome; Atrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmia, Sinus; Heart Block; Cardiac Conduction System Disease

Study Officials

• Ilya B. Lukin, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilya B. Lukin, MD, PhD

CONTACT

+7 906 656 2630; prlukin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 12, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)