OVEL II

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0009208
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients who are 19 years of age or older and have agreed to the study (if voluntary consent is deemed difficult, the consent of the legal representative shall be obtained together)
2. Patients requiring permanent pacemaker insertion due to the following reasons
- 3 degree atrioventricular block
- Patients expected to have ventricular heartbeat of 40% or more due to ventricular blockages of 1 or 2 degrees

Exclusion Criteria

1. Patients who have had a past pacemaker or defibrillator inserted
2. Patients with left ventricular ejection fraction (LVEF) of 50% or less
3. a patient with an indication of scrupulous infusion
4. Patients with a life expectancy of less than one year. (e.g., patients who can't even have a heart transplant,),
patients undergoing DNR, patients in hospice wards for refusing life-sustaining treatment, end-stage cancer patients who are unable to receive radiation or chemotherapy, etc.)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eft ventricular ejection fraction at 12 months of procedure (LVEF)

Secondary Outcome Measures

Name	Time	Method
Side effects related to the procedure;heart death;hospitalization due to heart failure;Echocardiographic findings (ventricular septal thickness, end-systolic left ventricular volume, end-systolic left ventricular Volume, diastolic function index, left atrial diameter, left atrial volume index, mitral valve, tricuspid valve degree of reflux, right ventricular contractile force, right ventricular contractile pressure);ECG results (QRS area and shape, QT interval, degree of T-wave fluctuation, LVAT, V6-V1 interpeak interval);Blood test results (NTproBNP);Procedural indicators (success or failure, procedure time, radiation time, LV activation time, V6-V1 peak to peak interval);Pacemaker Indicator (success or failure, procedure time, radiation time, LV activation time, V6-V1 peak to peak interval)