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

RECRUITINGN/ASponsored by The First Affiliated Hospital with Nanjing Medical University
Actively Recruiting
PhaseN/A
SponsorThe First Affiliated Hospital with Nanjing Medical University
Started2023-09-21
Est. completion2027-03
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions3

Heart DiseaseHeart FailureIntraventricular Block

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