Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block)
- Conditions
- Left Bundle Branch Area PacingAtrioventricular BlockRight Ventricular PacingHeart Failure
- Interventions
- Device: Right ventricular pacingDevice: Left bundle branch area pacing
- Registration Number
- NCT04730921
- Lead Sponsor
- Fu Wai Hospital, Beijing, China
- Brief Summary
This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block.
- Detailed Description
LEAP-BLOCK is a prospective, multi-center, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may reduce the risk of RV ventricular pacing induced cardiac dysfunction as compared with traditional RV pacing (RVP) in patients with atrioventricular (AV) block and normal LV function (LVEF≥50%) who require high percent of ventricular pacing. The primary aim of this trial is to compare the time to first event (composite of all-cause mortality and newly heart failure hospitalization and device upgrade due to heart failure) between LBBAP and RVP group in patients with AV block. Patients with AV block and normal LV function who require high burden of ventricular pacing (expected \>40%) will be randomized to LBBAP or RVP group for therapy. Patients will be followed at least every 3 months for clinical status and every 6 months for echocardiographic evaluation until the study closure.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 458
- a. Adult patients aged 18-90;
- b. AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a)Third-degree AV block; (b) Second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d)Symptomatic first degree AV block and PR interval on ECG ≥ 250ms;
- c. The subject is able to receive a pectoral implant;
- d. The subject is willing and able to comply with the protocol;
- e. The subject is expected to remain available for follow-up visits at the study centers.
- f. Subject or authorized legal guardian or representative has signed and dated the study Subject Informed Consent
- a. Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%);
- b. Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
- c. Patients with persistent atrial fibrillation;
- d. Pacemaker replacement without new implanted ventricular electrodes;
- e. Patients with implantable cardioverter-defibrillator (ICD) indications;
- f. Surgery is required within 1 year due to severe structural heart disease;
- g. Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc), or AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM)vpost (modified) Morrow surgery, (b) ventricular septal defect repair; and those who are unlikely to achieve successful LBBAP procedure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RVP group Right ventricular pacing AV block patients randomized to right ventricular pacing group LBBAP group Left bundle branch area pacing AV block patients randomized to left bundle branch area pacing
- Primary Outcome Measures
Name Time Method The primary endpoint is the time to a first event of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced heart failure. Within two years after device implantation All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.
Upgrade to cardiac resynchronization therapy (CRT): Upgrade from dual-chamber pacemaker to CRT-Pacemaker/CRT-Defibrillator due to impaired LV function (LVEF decrease to 40% or less).
- Secondary Outcome Measures
Name Time Method Rate of the composite outcomes of all-cause death and/or hospitalization for heart failure Within 2 years after device implantation All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.
The time to a first event of LVEF <50% and decrease in LVEF by ≥ 10% during 2 years follow-up as compared with the value at randomization. 24 months Echocardiography will be assessed every 6 month during follow-up to determine whether the LVEF is less than 50% and decreased by 15% or more as compared with the value at randomization.
Atrial high-rate episodes recorded by the pacemaker 24 months Atrial high-rate episodes recorded in the pacemaker will be followed during two years of follow-up
Rate of the composite outcomes of hospitalization for heart failure and/or an upgrade to cardiac resynchronization therapy due to pacing induced heart failure. Within 2 years after device implantation Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.
Upgrade to cardiac resynchronization therapy: Upgrade from dual chamber pacemaker to CRT-P/CRT-D due to impaired LV function (LVEF decrease to 40% or less).The occurrence of LV dyssynchrony 24 months The occurrence of LV dyssynchrony will be evaluated by echocardiography during 2-year follow-up.
Rate of the composite outcomes of LVEF <50%, and/or an increase in LVESV ≥15% during follow-up as compared with the value at randomization Within 2 years after device implantation Echocardiography will be assessed every 6 month during follow-up to determine whether the LVEF is less than 50% and/or the LVESV is increased by 15% or more.
The value of LVEF and LVESV assessed by echocardiography at 1-year and 2-year follow-up 24 months Echocardiography will be assessed at 1-year, and 2-year follow-up and the absolute value of LVEF and LVESV will be compared between two groups.
The immediate success rate of the LBBAP procedure 1 weeks Successful LBBAP procedure is identified according to ECG and intracardiac electrogram (IEGM) during the procedure. All LBBAP procedures will be categorized as selective left bundle branch pacing (S-LBBP), non-selective left bundle branch pacing(NS-LBBP), or left ventricular septal pacing (LVSP).
The rate of procedure and Device related complications 24 months Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications.
Changes in Pacing parameters and ECG characteristics. 24 months Pacing parameters include pacing thresholds (ventricle), Sense ampitude (ventricle), Impedance (ventricle). ECG characteristics include paced QRS duration and QRS morphology, etc.
The long-term success rate of LBBAP 24 months In LBBAP group, the successful LBBAP will be identified according ECG features at 2-years follow-up
Trial Locations
- Locations (8)
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Teda International Cardiovascular Hospital
🇨🇳Tianjin, Tianjin, China
Beijing Anzhen hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Fuwai Central China Cardiovascular Hospital
🇨🇳Zhengzhou, Henan, China