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

Pacemaker Complication Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03475498
• Other study ID #: EMC 2018-01-013
• Status: Recruiting
• Start date: March 1, 2018
• Est. completion date: February 28, 2028

Study information

• Verified date: March 2022
• Source: Eulji University Hospital
• Contact: Ki-Woon Kang, MD., PhD.
• Phone: 81 10 4492 2136
• Email: kwkang0115[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 28, 2028
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

3. Below preserved left ventricular dysfunction in the echocardiogram

4. Above 15% pacing-rhythm in the device interrogation

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

Related Conditions & MeSH terms

• Pacemaker Complication

Locations

Country	Name	City	State
Korea, Republic of	Chung-Buk University Hospital	Chungju
Korea, Republic of	Chung-Nam University Hospital	Daejeon

Sponsors (4)

Lead Sponsor	Collaborator
Eulji University Hospital	Chungbuk National University Hospital, Chungnam National University Hospital, Dankook University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Chin JY, Kang KW, Park SH, Choi YJ, Jung KT, Lee S, Youn HJ. Pre-implant global longitudinal strain as an early sign of pacing-induced cardiomyopathy in patients with complete atrioventricular block. Echocardiography. 2021 Feb;38(2):175-182. doi: 10.1111/echo.14942. Epub 2021 Jan 6. — View Citation

Kim JH, Kang KW, Chin JY, Kim TS, Park JH, Choi YJ. 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. BMJ Open. 2018 Feb 8;8(2):e019048. doi: 10.1136/bmjopen-2017-019048. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure diagnosis and treatment	Occurrence of heart failure symptom, diagnosis and treatment	5 years
Secondary	Atrial and Ventricular arrhythmia diagnosis, heart failure admisssion and all-caused mortality	Occurrence of atrial, ventricular arrhythmia, hear failure admission and all-cause mortality	5 years