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Comparison of left bundle branch area pacing and minimized ventricular pacing in patients with sinus nodedysfunction and atrioventricular dromotropathy: A Multicenter, randomized controlled, clinical trial

Not Applicable
Conditions
Diseases of the circulatory system
Registration Number
KCT0009577
Lead Sponsor
Asan Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
130
Inclusion Criteria

>18 years old
- Sinus node dysfunction with symptoms
- Atrioventricular conduction delay (PR interval > 180ms)

Exclusion Criteria

- Subject was unable to provide written informed consent or participate in long-term follow-up.
- Permanent atrial fibrillation
- Persistent advanced atrioventricular conduction disturbance (Mobitz type II or 3rd degree) with >40% of expected ventricular pacing burden
- Mechanical tricuspid valve
- Ventricular septal defect or scar
- Left ventricular ejection fraction < 35% who indicated cardiac resynchronization therapy
- Previous heart transplantation
- Pregnant and/or lactating women.
- Life expectancy <2 year
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
death;heart failure;new onset permanent atrial fibrillation
Secondary Outcome Measures
NameTimeMethod
death rate;stroke;cardiac re-hospitalization;re-implant;atrial fibrillation;atrial fibrillation;atrial fibrillation;Procedure time;LBBAP success rate;LV ejection fraction;LV dimension;LA dimension;Valvular heart disease;E/e’ value;sensing value, pacing threshold, impedance
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