A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
Recruiting
N/AInterventional Study
Heart FailureIntraventricular Block
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
86 (estimated)
Sponsor
The First Affiliated Hospital with Nanjing Medical University · Other
Who this trial is looking for
This trial is looking for people with chronic heart failure and a specific heart condition called intraventricular block to see if a new treatment, LOT-CRT, works better than a standard treatment. If you qualify, you will receive one of the treatments and be followed for at least six months.
Are You a Good Fit for This Trial?
You may be able to join if
I have chronic heart failure.
I have been on optimal medical therapy for at least 3 months.
I am in NYHA class II-IV.
My LVEF is 35% or less.
I have sinus rhythm, though I may have occasional atrial fibrillation.
My QRS duration is 150ms or more.
I have intraventricular block.
You may not be able to join if
I have had heart valve surgery or need it.
I have had a mechanical tricuspid valve replacement.
I have persistent or permanent atrial fibrillation or flutter.
I have second or third degree atrioventricular block.
I have had a heart attack in the past 3 months.
My expected survival time is less than 12 months.
I am pregnant or plan to conceive.
I have ventricular septal hypertrophy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 effe…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Ischemic or non ischemic cardiomyopathy
2. Optimal medical therapy for at lest 3 months
3. NYHA class II-IV
4. LVEF≤35% as assessed by echocardiography
5. Sinus rhythm (may have paroxysmal atrial fibrillation)
6. QRS duration ≥ 150ms
7. Intraventricular block (NICD), QRS morp…
Inclusion Criteria:
1. Ischemic or non ischemic cardiomyopathy
2. Optimal medical therapy for at lest 3 months
3. NYHA class II-IV
4. LVEF≤35% as assessed by echocardiography
5. Sinus rhythm (may have paroxysmal atrial fibrillation)
6. QRS duration ≥ 150ms
7. Intraventricular block (NICD), QRS morphology is neither LBBB nor RBBB
Exclusion Criteria:
1. Valvular heart disease that requires or has undergone surgical intervention
2. After mechanical tricuspid valve replacement
3. Persistent or permanent atrial fibrillation or atrial flutter
4. Second or third degree atrioventricular block
5. Have a history of acute myocardial infarction within 3 months prior to enrollment
6. Patient's expected survival time is less than 12 months
7. Pregnant or planned to conceive
8. Ventricular septal hypertrophy (ventricular septal thickness exceeds 15mm at the end of diastole)
9. Patients with simple and persistent left superior vena cava
10. Patients with existing pacemaker implantation
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