Status:
UNKNOWN
LVSP Based CRT vs. RVAP Based CRT
Lead Sponsor:
Fu Wai Hospital, Beijing, China
Conditions:
Heart Failure
Cardiac Resynchronization Therapy
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bun...
Eligibility Criteria
Inclusion
- 1\. Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing; 3. Age between 18 and 90 years old; 4. The expected survival period is greater than 12 months; 5. Signed the informed consent form for the study.
Exclusion
- Previous mechanical tricuspid valve replacement.
- Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.
- Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.
- Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.
- Patients participated in any of the other studies at the same time, which may confound the results of this study.
- Pregnancy, planning to become pregnant.
- 8\. Patients with a history of heart transplantation.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05985408
Start Date
September 1 2023
End Date
September 1 2025
Last Update
August 14 2023
Active Locations (1)
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1
Fuwai hospital
Beijing, Beijing Municipality, China, 100037