A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
Recruiting · NCT06061627 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
BiVP groupLOT-CRT group
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- The First Affiliated Hospital with Nanjing Medical University - Nanjing, Jiangsu, China