Atrial Fibrillation, Atrioventricular Block, Sick Sinus Syndrome
Conditions
Keywords
Pacemaker, Dual-chamber pacing, Pacemaker algorithms, Conduction system pacing, His bundle pacing, Left bundle branch pacing, Catheter ablation, Cryoablation, Arrhythmia prevention
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.
Interventions
None listed
Sponsors
Ilya Lukin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Permanent Atrial Fibrillation (%) | Up to 3 years of follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality Rate (number of participants) | Up to 3 years | Death from any cause during follow-up, according to clinical documentation and death registry data |
| AF Burden (% of time in atrial fibrillation) | Up to 3 years | Percentage of time in atrial fibrillation recorded by device diagnostics (atrial high-rate episodes / AT/AF detection) |
| Mean Left Atrial Pressure During Pacing (mmHg) | Baseline intraoperative | Intraoperative measurement of mean left atrial pressure according to pacing site. |
| Change in Left Atrial Volume Index (mL/m²) | Baseline intraoperative + up to 12 months follow-up | Change from baseline in left atrial volume index measured by transthoracic echocardiography according to pacing site. |
Countries
Russia
Contacts
Primary ContactIlya B. Lukin, MD, PhD
Outcome results
None listed