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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.
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.
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| 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 |
| 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) |
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Inclusion Criteria:
• Age ≥ 18 years
Exclusion Criteria:
• Single-chamber pacemaker or Cardiac Resynchronization Therapy device at baseline
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Consecutive adult patients undergoing implantation of dual-chamber pacemakers at Tver State Medical University and affiliated hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilya B. Lukin, MD, PhD | Contact | +7 906 656 2630 | prlukin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ilya B. Lukin, MD, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tver State Medical University Clinical Center | Tver' | Tver Oblast | 170000 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
| Label | URL |
|---|---|
| Author Open Researcher and Contributor ID (ORCID Profile) (Ilya B. Lukin) | View source |
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No, but available on request
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D012804 | Sick Sinus Syndrome |
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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 |
| Pilot study on atrial pacing algorithms and atrial fibrillation (Lukin et al., 2025) | View source |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001146 | Arrhythmia, Sinus |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |