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

Summary

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.

Conditions

• Heart Failure
• Intraventricular 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Fu Wai Hospital, Beijing, China

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Shanghai Tong Ren Hospital

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Principal Investigators

• Jiangang Zou · The First Affiliated Hospital with Nanjing Medical University

• Yangang Su · Shanghai Zhongshan Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-21

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• China

Study Locations