A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
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
The First Affiliated Hospital with Nanjing Medical University
86 participants
Sep 21, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Ischemic or non ischemic cardiomyopathy
- Optimal medical therapy for at lest 3 months
- NYHA class II-IV
- LVEF≤35% as assessed by echocardiography
- Sinus rhythm (may have paroxysmal atrial fibrillation)
- QRS duration ≥ 150ms
- Intraventricular block (NICD), QRS morphology is neither LBBB nor RBBB
Exclusion Criteria10
- 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
- Have a history of acute myocardial infarction within 3 months prior to enrollment
- Patient's expected survival time is less than 12 months
- Pregnant or planned to conceive
- Ventricular septal hypertrophy (ventricular septal thickness exceeds 15mm at the end of diastole)
- Patients with simple and persistent left superior vena cava
- Patients with existing pacemaker implantation
Interventions
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).
Implantation of a LV pacing lead is attempted using the standard-of-care technique first.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06061627