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

Recruiting

• Conditions: Pacemaker Complication

• Registration Number: NCT03475498
• Lead Sponsor: Eulji University Hospital

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

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-03-18
• Study First Posted: 2018-03-23
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01
• Primary Completion: 2023-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart failure diagnosis and treatment	5 years	Occurrence of heart failure symptom, diagnosis and treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Chung-Nam University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Chung-Buk University Hospital; 🇰🇷 Chungju, Korea, Republic of