Status:
UNKNOWN
Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy
Lead Sponsor:
Fu Wai Hospital, Beijing, China
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Heart Failure
Left Bundle Branch Pacing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a two-center, prospective randomized controlled trial. The aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and gu...
Detailed Description
Early-resync is a two-center, prospective randomized controlled trial that is designed to determine whether early left bundle branch pacing has a better impact on LV function improvement as compared w...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- symptomatic heart failure despite guideline-directed medical therapy for at least 3 months, NYHA class II-IV, with an EF between 35% and 50%;
- complete LBBB meeting Strauss's standard definition
- Signed informed consent.
Exclusion
- Expected survival less than 24 months;
- Indicated for ICD or pacing therapy;
- History of VT, VF, or hemodynamic instability;
- History of mechanical tricuspid valve replacement;
- Ischemic cardiomyopathy scheduled for CABG and PCI within 3 months;
- Severe structural heart disease may necessitate cardiac surgery or heart transplantation within 1 year;
- Pregnancy or planning for pregnancy;
- Hypertrophic cardiomyopathy or those underwent ventricular septal defect repair, in whom the success of LBBP is anticipated to be challenging;
- Severe renal dysfunction (eGFR \< 15ml/min\*1.73m\^2).
Key Trial Info
Start Date :
June 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06126081
Start Date
June 26 2023
End Date
December 30 2025
Last Update
November 13 2023
Active Locations (2)
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1
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
2
The first affiliated hospital of Nanjing medical university
Nanjing, Jiangsu, China