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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03475498
Other study ID # EMC 2018-01-013
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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