Actively Recruiting

Age: 20Years +
All Genders
ID03475498

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

On this page

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

Eligible

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
Not Eligible

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

AI-Screening

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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.

Regular follow-up visits over 5 years

Trial Site Locations

Total: 3 locations

1

Chung-Buk University Hospital

Chungju, South Korea

Actively Recruiting

2

Chung-Nam University Hospital

Daejeon, South Korea

Actively Recruiting

3

Chung-Ang University Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

K

Ki-Woon Kang, MD., PhD.

H

Hyu Ryung Cho

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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.

Jun Hyung Kim, Ki-Woon Kang, Jung Yeon Chin...

https://pubmed.ncbi.nlm.nih.gov/29439074

Pre-implant global longitudinal strain as an early sign of pacing-induced cardiomyopathy in patients with complete atrioventricular block.

Jung Yeon Chin, Ki-Woon Kang, Sang Hyun Park...

https://pubmed.ncbi.nlm.nih.gov/33406280