Status:
RECRUITING
A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Sir Run Run Shaw Hospital
Conditions:
Heart Failure
Intraventricular Block
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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) ...
Detailed Description
Cardiac resynchronization therapy is a standardized treatment strategy for patients with chronic heart failure complicated by wide QRS waves. With the continuous development of physiological pacing te...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06061627
Start Date
September 21 2023
End Date
March 1 2027
Last Update
March 13 2025
Active Locations (1)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029