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A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD

RecruitingNAAges 18 Years - 80 YearsAllThe First Affiliated Hospital with Nanjing Medica…
NCT06061627 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • LOT-CRT group
  • BiVP group
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Where

1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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