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A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
Sponsor: The First Affiliated Hospital with Nanjing Medical University
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.
Official title: A Randomized Controlled Trial of Left Bundle brAnch opTimized Cardiac Resynchronization Therapy Versus conventionaL Bi-vEntricular Pacing in Heart Failure Patients With Nonspecific Intraventricular Conduction Delay
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2023-09-21
Completion Date
2027-03
Last Updated
2025-03-13
Healthy Volunteers
No
Conditions
Interventions
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).
BiVP group
Implantation of a LV pacing lead is attempted using the standard-of-care technique first.
Locations (1)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China