Tver State Medical University Clinical Center
Tver', Tver Oblast, 170000, Russia
Location contact
Ilya B. Lukin, MD, PhD
CONTACT
Ilya B. Lukin, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07279207
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Tver', Tver Oblast, 170000, Russia
Ilya B. Lukin, MD, PhD
CONTACT
Ilya B. Lukin, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: Up to 3 years
Death from any cause during follow-up, according to clinical documentation and death registry data
Time frame: Up to 3 years
Percentage of time in atrial fibrillation recorded by device diagnostics (atrial high-rate episodes / AT/AF detection)
Time frame: Baseline intraoperative
Intraoperative measurement of mean left atrial pressure according to pacing site.
Time frame: Baseline intraoperative + up to 12 months follow-up
Change from baseline in left atrial volume index measured by transthoracic echocardiography according to pacing site.
Contact information is provided by the study sponsor or research team.
Ilya Lukin
Other
Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation (PACE-AF)
Acronym: PACE-AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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