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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Atrioventricular Block; Sick Sinus Syndrome

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Ilya B. Lukin, MD, PhD; Phone Number: +7 906 656 2630; Email: prlukin@gmail.com

Study Locations

• Russia
  • Tver Oblast
    • Tver', Tver Oblast, Russia, 170000
      • Tver State Medical University Clinical Center
      • Contact: Ilya B. Lukin, MD, PhD; Phone Number: +79066562630; Email: prlukin@gmail.com
      • Principal Investigator: Ilya B. Lukin, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality Rate (number of participants)	Death from any cause during follow-up, according to clinical documentation and death registry data	Up to 3 years
AF Burden (% of time in atrial fibrillation)	Percentage of time in atrial fibrillation recorded by device diagnostics (atrial high-rate episodes / AT/AF detection)	Up to 3 years
Mean Left Atrial Pressure During Pacing (mmHg)	Intraoperative measurement of mean left atrial pressure according to pacing site.	Baseline intraoperative
Change in Left Atrial Volume Index (mL/m²)	Change from baseline in left atrial volume index measured by transthoracic echocardiography according to pacing site.	Baseline intraoperative + up to 12 months follow-up

Collaborators and Investigators

• Sponsor: Ilya Lukin
• Investigators: Principal Investigator: Ilya B. Lukin, MD, PhD, Principal Investigator

Publications and helpful links

General Publications

• 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

Helpful 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)

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Catheter ablation; Cryoablation; Pacemaker; His bundle pacing; Left bundle branch pacing; Conduction system pacing; Dual-chamber pacing; Pacemaker algorithms; Arrhythmia prevention
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Arrhythmia, Sinus; Pathological Conditions, Signs and Symptoms; Atrioventricular Block; Sick Sinus Syndrome; Atrial Fibrillation
• Other Study ID Numbers: PACE-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, but available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No