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NCT Number: NCT03475498

A Major Determinant Focused on the ECG or Echocardiogram for PICM and Its Clinical Outcome (PICM Syndrome)

Chronic right ventricular pacing has a deleterious effect on left ventricular (LV) function, namely pacing-induced cardiomyopathy (PICM). Several parametes make difference of effect on the occurrence of PICM and its subsequent clinical outcomes. In particular, recognition of a major determinant focused on the ECG or echocardiographic parameters including strain or genetic factor for occurrence of PICM may lead to better identification of patients at high risk. Investigators prospectively enroll a participant with documented high risk of PICM and clinically follow-up to idenify clinical impact of PICM (PICM syndrome) over a long period of time.

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Key information

Conditions

Pacemaker Complication

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chung-Buk University Hospital, Chungju, South Korea

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About this study

Investigators investigate a major determinant focused on the ECG or echocardiogram or genetic factor to predict the PICM after implantation of pacemaker. Not only QRS duration and mechanical strain but also genetic factor could be also investigated to predict the occurrence of PICM before diagnosis fo PICM

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

mandatory (1 and 2) and optional (3 or 4)

  • Willng to participate in the study and able to sign informed consent
  • Undertaken ECG and echocardiogram including strain before and after device implantation

Exclusion criteria

  • Less than 18 years of age
  • Being pregnant or plan to become pregnant
  • Advanced heart failure waiting in heart transplantation
  • Have a life expectancy of less than 1 year

Treatment and study plan

Primary outcomes

  1. Heart failure diagnosis and treatment

    Time frame: 5 years

    Occurrence of heart failure symptom, diagnosis and treatment

Secondary outcomes

  1. Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality

    Time frame: 5 years

    Occurrence of atrial, ventricular arrhythmia, hear failure admission and all-cause mortality

Study contacts

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

Hyu Ryung Cho

CONTACT

Ki-Woon Kang, MD., PhD.

CONTACT

[email protected]

81 10 4492 2136

Sponsors and collaborators

Lead sponsor

Eulji University Hospital

Other

Collaborators

  • Chung-Ang University Hospital
  • Chungbuk National University Hospital
  • Chungnam National University Hospital
  • Dankook University

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Mar 23, 2018
Registry last updated
Oct 2, 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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