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

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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03475498

Enrollment

1000

Registered

2018-03-23

Start date

2018-01-30

Completion date

2028-02-28

Last updated

2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacemaker Complication

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

mandatory (1 and 2) and optional (3 or 4) 1. Willng to participate in the study and able to sign informed consent 2. Undertaken ECG and echocardiogram including strain before and after device implantation

Exclusion criteria

1. Less than 18 years of age 2. Being pregnant or plan to become pregnant 3. Advanced heart failure waiting in heart transplantation 4. Have a life expectancy of less than 1 year

Design outcomes

Primary

Measure	Time frame	Description
Heart failure diagnosis and treatment	5 years	Occurrence of heart failure symptom, diagnosis and treatment

Secondary

Measure	Time frame	Description
Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality	5 years	Occurrence of atrial, ventricular arrhythmia, hear failure admission and all-cause mortality

Countries

South Korea

Contacts

Primary ContactKi-Woon Kang, MD., PhD.

kwkang0115@gmail.com81 10 4492 2136

Backup ContactHyu Ryung Cho

Outcome results