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临床试验/NCT07279207
NCT07279207尚未招募不适用

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

Ilya Lukin1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
Incidence of Permanent Atrial Fibrillation (%)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Age ≥ 18 years
  • Implantation of a dual-chamber permanent pacemaker
  • Ability to provide informed consent
  • Willingness to participate in long-term follow-up

排除标准

  • • 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

结局指标

主要结局

Incidence of Permanent Atrial Fibrillation (%)

时间窗: 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

次要结局

  • Mean Left Atrial Pressure During Pacing (mmHg)(Baseline intraoperative)
  • AF Burden (% of time in atrial fibrillation)(Up to 3 years)
  • All-Cause Mortality Rate (number of participants)(Up to 3 years)
  • Change in Left Atrial Volume Index (mL/m²)(Baseline intraoperative + up to 12 months follow-up)

研究者

发起方
Ilya Lukin
申办方类型
Other
责任方
Sponsor

研究点 (1)

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