Status:
COMPLETED
The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT)
Lead Sponsor:
Tau-MEDICAL Co., Ltd.
Conditions:
Heart Failure
LBBB Complete
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
trans-coronary sinus intraseptal pacing (cerclage pacing)
Detailed Description
This study is aimed at looking at the effect of "Cerclage pacing" for the heart failure patients who need cardiac resynchronization therapy (CRT). The study hypothesis is that parahisian pacing by 'ce...
Eligibility Criteria
Inclusion
- who need cardiac resynchronization therapy (CRT) or CRT-non responder
- Left bundle branch block \[LBBB\]) \> 120ms of QRS width
- Ejection fraction (EF) \< 35%
- NYHA class III-IV in spite of optimal medical Tx
Exclusion
- Unsuitable coronary vein anatomy on cardiac CT
- Subjects with prosthetic mechanical tricuspid valve
- Active infection
- Life expectancy less than 6 months
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03438591
Start Date
March 5 2018
End Date
June 30 2019
Last Update
September 11 2019
Active Locations (1)
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1
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50602