PACE-AF: Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Sick Sinus Syndrome, Atrioventricular Block. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation (PACE-AF)
Overview
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.
Primary outcome measures
- Incidence of Permanent Atrial Fibrillation (%) [Time frame: Up to 3 years of follow-up]
Secondary outcome measures (4)
- All-Cause Mortality Rate (number of participants) [Time frame: Up to 3 years]
- AF Burden (% of time in atrial fibrillation) [Time frame: Up to 3 years]
- Mean Left Atrial Pressure During Pacing (mmHg) [Time frame: Baseline intraoperative]
- Change in Left Atrial Volume Index (mL/m²) [Time frame: Baseline intraoperative + up to 12 months follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Russia · 1 center
- Tver State Medical University Clinical Center — Tver'
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
Identifiers
NCT: NCT07279207 · PACE-AF