Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy Compared With Guideline-directed Medical Therapy in Heart Failure With Mild-reduced Ejection Fraction.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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 guideline-directed medical therapy in heart failure with mild-reduced ejection fraction.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
RECRUITING
Beijing
The first affiliated hospital of Nanjing medical university
NOT_YET_RECRUITING
Nanjing
Contact Information
Primary
Chen He, M.D
18059707043@163.com
+8618059707043
Backup
Haojie Zhu, M.D
13167310573@163.com
+8613167310573
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 36
Treatments
Experimental: LBBP+GDMT group
Patients in the LBBP+GDMT group will receive LBBP using dual-chamber device as priority and guideline-directed medical therapy. The pacing lead will be implanted at the left bundle branch and whether LBB is captured will be judged during the procedure. For patients who LBBP is failed, CRTP using triple-chamber device or LVSP by using dual-chamber device will be an alternative option according to the co-determination after consultation between doctors and patients .
Active_comparator: GDMT group
Patients in the GDMT group will receive guideline-directed medical therapy according to their complications, heart rate, blood pressure and so on. During follow-up of 6 months, patients may transfer to LBBP group if the LVEF decreased to \<35% and patients accepted the device implantation.
Related Therapeutic Areas
Sponsors
Leads: Fu Wai Hospital, Beijing, China
Collaborators: The First Affiliated Hospital with Nanjing Medical University