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Clinical Trials/NCT03475498
NCT03475498
Recruiting
Not Applicable

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.

Eulji University Hospital3 sites in 1 country1,000 target enrollmentJanuary 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pacemaker Complication
Sponsor
Eulji University Hospital
Enrollment
1000
Locations
3
Primary Endpoint
Heart failure diagnosis and treatment
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
January 30, 2018
End Date
February 28, 2028
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Eulji University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ki-Woon Kang, MD

Professor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

Heart failure diagnosis and treatment

Time Frame: 5 years

Occurrence of heart failure symptom, diagnosis and treatment

Secondary Outcomes

  • Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality(5 years)

Study Sites (3)

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