BATTLE study has been designed as a prospective, multi-center, randomized, controlled trial. This study will enroll 83 patients with chronic heart failure accompanied by intraventricular block (NICD) over an estimated recruitment period of 3 years. An LOT-CRT group will be compared with a group of conventional BiVP in the follow-up of at least 6 months. The study aimed to compare the curative effect of LOT-CRT in preserving LV systolic function with traditional BiVP in chronic heart failure patients with NICD.
Ischemic or non ischemic cardiomyopathy
Optimal medical therapy for at lest 3 months
NYHA class II-IV
LVEF≤35% as assessed by echocardiography
Valvular heart disease that requires or has undergone surgical intervention
After mechanical tricuspid valve replacement
Persistent or permanent atrial fibrillation or atrial flutter
Second or third degree atrioventricular block
Parallel
LOT-CRT group
Procedure/SurgeryIn 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).
BiVP group
Procedure/SurgeryImplantation of a LV pacing lead is attempted using the standard-of-care technique first.
Left ventricular ejection fraction(LVEF)
Changes from baseline LVEF(unit: %) assessed by echocardiography at follow-up
Paced QRS duration
Paced QRS duration is evaluated postoperative day 1 and 1 months, 3 months and 6 months after implantation.
A combined clinical endpoint of all-cause mortality and heart failure hospitalization,
Including date and number of all-cause mortalityand heart failure hospitalization,
Left ventricular end systolic volume(LVESV)
Changes from baseline LVESV(unit: mL) assessed by echocardiography at follow-up
Left ventricular end diastolic volume(LVEDV)
Changes from baseline LVEDV(unit: mL) assessed by echocardiography at follow-up
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Fu Wai Hospital, Beijing, China
Collaborator
West China Hospital
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
The First People's Hospital of Yunnan
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Shanghai Tong Ren Hospital
Collaborator
Fujian Provincial Hospital
Collaborator
Fujian Medical University Union Hospital
Collaborator
