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.
Study Type
OBSERVATIONAL
Enrollment
500
Tver State Medical University Clinical Center
Tver', Tver Oblast, Russia
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
Time frame: Up to 3 years of follow-up
All-Cause Mortality Rate (number of participants)
Death from any cause during follow-up, according to clinical documentation and death registry data
Time frame: 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)
Time frame: Up to 3 years
Mean Left Atrial Pressure During Pacing (mmHg)
Intraoperative measurement of mean left atrial pressure according to pacing site.
Time frame: 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.
Time frame: Baseline intraoperative + up to 12 months follow-up
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