A Major Determinant Focused on the ECG or Echocardiogram for Pacing-induced Cardiomyopathy (PICM) and Its Clinical Outcome (PICM Syndrome) : Prospective, Multi-center, Observational Cohort Study.
Led by Eulji University Hospital · Updated on 2025-10-02
1000
Participants Needed
3
Research Sites
52 weeks
Total Duration
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Sponsors
E
Eulji University Hospital
Lead Sponsor
C
Chungnam National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying pacing-induced cardiomyopathy (PICM), a condition where chronic right ventricular pacing harms left ventricular function. This observational study focuses on ECG and echocardiogram parameters, including strain, as well as genetic factors, to identify patients at high risk of developing PICM after pacemaker implantation. The goal is to better predict who might develop PICM and understand its clinical impact over time.
Participants will have ECG and echocardiogram tests before and after pacemaker implantation to assess key measurements such as QRS duration and mechanical strain. Genetic factors may also be evaluated to improve prediction of PICM occurrence. This study involves long-term follow-up to monitor the condition and its outcomes.
During the study, participants will be clinically followed for up to 5 years to observe heart failure diagnosis and treatment. Researchers will also track atrial and ventricular arrhythmias, hospital admissions for heart failure, and overall mortality. The study does not involve treatment interventions but focuses on monitoring and data collection to understand PICM and its clinical outcomes.
CONDITIONS
Brief Title
A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)
Who Can Participate
Age: 20Years +
All Genders
Eligibility Criteria
You may qualify if you...
Willing to participate in the study and able to sign informed consent
Undertaken ECG and echocardiogram including strain before and after device implantation
You will not qualify if you...
Less than 18 years of age
Being pregnant or planning to become pregnant
Advanced heart failure waiting for heart transplantation
Have a life expectancy of less than 1 year
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline and post-implantation assessments
Participants undergo ECG and echocardiogram assessments including strain measurements before and after pacemaker implantation to investigate major determinants of pacing-induced cardiomyopathy (PICM).
At least 2 visits (in-person)
Long-term Monitoring
Duration - 5 years
Participants are monitored for clinical outcomes including heart failure diagnosis, arrhythmias, hospital admissions, and mortality over a 5-year period after device implantation.
Major determinant of the occurrence of pacing-induced cardiomyopathy in complete atrioventricular block: a multicentre, retrospective analysis over a 15-year period in South Korea.