PACE-AF: Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIlya Lukin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Age ≥ 18 years
Implantation of a dual-chamber permanent pacemaker
Ability to provide informed consent
Willingness to participate in long-term follow-up
Disqualifiers
• 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
Trial population
Consecutive adult patients undergoing implantation of dual-chamber pacemakers at Tver State Medical University and affiliated hospitals.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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-upSecondary outcomes
1
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 years2
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 years3
Mean Left Atrial Pressure During Pacing (mmHg)
Intraoperative measurement of mean left atrial pressure according to pacing site.
Time frame
Baseline intraoperative4
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 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: