Comparing LOT-CRT and conventional BiVP in heart failure patients with intraventricular block
A Randomized Controlled Trial of Left Bundle brAnch opTimized Cardiac Resynchronization Therapy Versus conventionaL Bi-vEntricular Pacing in Heart Failure Patients With Nonspecific Intraventricular Conduction Delay
This study is testing whether a new heart pacing method called LOT-CRT works better than the standard biventricular pacing for people with chronic heart failure and a specific heart block.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06061627 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to compare the effectiveness of left bundle branch area pacing (LOT-CRT) against conventional biventricular pacing (BiVP) in patients suffering from chronic heart failure with intraventricular block. The study will enroll 83 patients over a three-year period and will follow them for at least six months to assess improvements in left ventricular systolic function. By utilizing a randomized controlled approach, the trial aims to provide insights into the potential advantages of LOT-CRT in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with ischemic or non-ischemic cardiomyopathy, NYHA class II-IV heart failure, and specific echocardiographic findings.
Not a fit: Patients with significant valvular heart disease, persistent atrial fibrillation, or those with a history of recent myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and quality of life for patients with chronic heart failure and intraventricular block.
How similar studies have performed: Previous studies have shown promising results for similar pacing techniques, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Jiangang Zou — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Jiangang Zou
- Email: jgzou@njmu.edu.cn
- Phone: 86-13605191407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.