NCT06061627 A Randomized Controlled Trial of LOT-CRT Versus conventionaL BiVP in Heart Failure Patients With NICD
| NCT ID | NCT06061627 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2023-09-21 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 86 participants in total. It began in 2023-09-21 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) 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 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 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
Contact & Investigator
Jiangang Zou
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06061627 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06061627 currently recruiting?
Yes, NCT06061627 is actively recruiting participants. Contact the research team at jgzou@njmu.edu.cn for enrollment information.
Where is the NCT06061627 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06061627 clinical trial?
NCT06061627 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Jiangang Zou at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 86 participants.
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