LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 14, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Non-ischemic CardiomyopathyHeart FailureLeft Bundle-Branch Block
Interventions
DRUG

Guideline-Directed Medical Therapy(GDMT)

"Quadruple anti-heart failure drug therapy: BB, ACEI/ARB/ARNI, MRA, and SGLT2i. If the initial dose according to guidelines is tolerated, the protocol would then direct the uptitration of medication dose over time to a specified target dose, unless not well tolerated.~\*Criteria for \<3 months of optimized (complete) GDMT: 1) according to the latest management of HF, any of the new quadruple therapy is not used if the condition allowed; Or 2) the dose of any drug dose not reach the maximum tolerated target; Or 3) under the maximum tolerated dose of BB, ivabradine is not added with a heart rate still ≥70 bpm at rest."

COMBINATION_PRODUCT

left bundle branch pacing combined with Guideline-Directed Medical Therapy(LBBP+GDMT)

"GDMT is the same as Drug intervention. LBBP is confirmed when: 1) the LBBB morphology disappeared and the paced RBBB pattern (typical or atypical) is observed in V1; and 2) LVAT is ≤100 ms at low output(≤3 V/0.5 ms); and at least 1 of the following is achieved: a) abrupt shortening of LVAT by \>10 ms during mid/deep septal lead placement with a RBBB pattern in V1 at high output, which then remains short and constant at high and low output with further advancement of the lead to the final position; b) transition from nonselective to selective LBBP (QRS morphology transition from atypical RBBB to typical rsR' pattern in V1 and wide/large S-wave in V6 , with the appearance of an isoelectric segment and no LVAT change at high and low outputs); and c) transition from nonselective LBBP to LV septal pacing (lengthening of LVAT by at least 10 ms with or without obvious QRS morphology transition during threshold testing).~HBP or BiVP is attempted using the standard-of-care technique."

Trial Locations (6)

210029

RECRUITING

The First Affiliated Hospital with Nanjing Medical University, Nanjing

Unknown

NOT_YET_RECRUITING

Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing

NOT_YET_RECRUITING

Fujian Medical University Union Hospital, Fuzhou

NOT_YET_RECRUITING

The First Affiliated Hospital of Dalian Medical University, Dalian

NOT_YET_RECRUITING

West China Hospital, Sichuan University, Chengdu

NOT_YET_RECRUITING

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

All Listed Sponsors
collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

collaborator

West China Hospital

OTHER

collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Fujian Medical University Union Hospital

OTHER

collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

lead

The First Affiliated Hospital with Nanjing Medical University

OTHER