A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD

NARecruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

September 21, 2023

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Heart FailureIntraventricular Block
Interventions
PROCEDURE

LOT-CRT group

"In addition to the leads implanted in BiVP group, it is also necessary to implant the left bundle branch area pacing(LBBAP) leads~LBBAP includes LBBP and LVSP.~LBBP is defined if fulfilling criterion 1 and at least one in criteria 2:~1. Paced morphology of RBBD in surface lead V1 (QR, Qr, rSr', rSR' or Qrs);~2. One of the following should be met, while the pacing threshold ≤ 1.5V/0.5ms:~ 1. Selective LBBP capture pattern appears, with an iso-electrical window between the pacing spike and QRS onset;~ 2. When reducing the output voltage, the LVAT undergoes a sudden change of\>10ms;~If criterion 1 is fulfilled but none in criteria 2 is met, the procedure is considered to be left ventricular septal pacing (LVSP)."

PROCEDURE

BiVP group

Implantation of a LV pacing lead is attempted using the standard-of-care technique first.

Trial Locations (1)

210029

RECRUITING

The First Affiliated Hospital with Nanjing Medical University, Nanjing

All Listed Sponsors
collaborator

Shanghai Zhongshan Hospital

OTHER

collaborator

Sir Run Run Shaw Hospital

OTHER

collaborator

Fu Wai Hospital, Beijing, China

OTHER

collaborator

West China Hospital

OTHER

collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

collaborator

The First People's Hospital of Yunnan

OTHER

collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Guangdong Provincial People's Hospital

OTHER

collaborator

Shanghai Tong Ren Hospital

OTHER

collaborator

Fujian Provincial Hospital

OTHER

collaborator

Fujian Medical University Union Hospital

OTHER

lead

The First Affiliated Hospital with Nanjing Medical University

OTHER