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NCT Number: NCT07279207

PACE-AF: Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tver State Medical University Clinical Center

Tver', Tver Oblast, 170000, Russia

Location contact

Ilya B. Lukin, MD, PhD

CONTACT

[email protected]

+79066562630

Ilya B. Lukin, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Permanent Atrial Fibrillation (%)

    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

Secondary outcomes

  1. All-Cause Mortality Rate (number of participants)

    Time frame: Up to 3 years

    Death from any cause during follow-up, according to clinical documentation and death registry data

  2. AF Burden (% of time in atrial fibrillation)

    Time frame: Up to 3 years

    Percentage of time in atrial fibrillation recorded by device diagnostics (atrial high-rate episodes / AT/AF detection)

  3. Mean Left Atrial Pressure During Pacing (mmHg)

    Time frame: Baseline intraoperative

    Intraoperative measurement of mean left atrial pressure according to pacing site.

  4. Change in Left Atrial Volume Index (mL/m²)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilya B. Lukin, MD, PhD

CONTACT

[email protected]

+7 906 656 2630

Sponsors and collaborators

Lead sponsor

Ilya Lukin

Other

Registry information

Official study title

Prospective Analysis of Cardiac Electrostimulation and Atrial Fibrillation (PACE-AF)

Acronym: PACE-AF

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

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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