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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Jiangang Zou
jgzou@njmu.edu.cn
86-13605191407
Time Frame
Start Date: 2023-09-21
Estimated Completion Date: 2027-03
Participants
Target number of participants: 86
Treatments
Experimental: LOT-CRT group
In this arm, an right artrial (RA) lead, an implantable cardioverter defibrillator (ICD) lead and a LV pacing lead are placed are conventionally implanted.~A left bundle branch pacing(LBBP) lead is attempted to be placed.
Active_comparator: BiVP group
In this arm, an RA lead , an ICD lead and a LV pacing lead are placed.
Related Therapeutic Areas
Sponsors
Collaborators: Fujian Provincial Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Dalian Medical University, West China Hospital, Guangdong Provincial People's Hospital, Fujian Medical University Union Hospital, Fu Wai Hospital, Beijing, China, The First People's Hospital of Yunnan, Shanghai Zhongshan Hospital, Shanghai Tong Ren Hospital, Sir Run Run Shaw Hospital
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov