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.
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chung-Buk University Hospital | Chungju | |
Korea, Republic of | Chung-Nam University Hospital | Daejeon |
Lead Sponsor | Collaborator |
---|---|
Eulji University Hospital | Chungbuk National University Hospital, Chungnam National University Hospital, Dankook University |
Korea, Republic of,
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
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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