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Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block) (LEAP-Block)

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ClinicalTrials.gov Identifier: NCT04730921
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : February 4, 2021
Sponsor:
Collaborators:
Beijing Anzhen Hospital
The First Affiliated Hospital of Zhengzhou University
The Second Hospital of Hebei Medical University
Fuwai Central China Cardiovascular Hospital
Tianjin Medical University General Hospital
Teda International Cardiovascular Hospital, Tianjin, China
Peking Union Medical College Hospital
Chinese Society of Cardiology
Information provided by (Responsible Party):
Fan Xiaohan, Chinese Academy of Medical Sciences, Fuwai Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrioventricular Block Left Bundle Branch Area Pacing Right Ventricular Pacing Heart Failure Device: Left bundle branch area pacing Device: Right ventricular pacing Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block): A Randomized Controlled Trial
Actual Study Start Date : November 13, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: LBBAP group
AV block patients randomized to left bundle branch area pacing
 Device: Left bundle branch area pacing
Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.
Active Comparator: RVP group
AV block patients randomized to right ventricular pacing group
 Device: Right ventricular pacing
Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. Rate of the composite outcomes of all-cause death and/or hospitalization for heart failure [ Time Frame: 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.

  2. Rate of the composite outcomes of hospitalization for heart failure and/or an upgrade to cardiac resynchronization therapy due to pacing induced heart failure. [ Time Frame: 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).


  3. 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 [ Time Frame: 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.

  4. The value of LVEF and LVESV assessed by echocardiography at 1-year and 2-year follow-up [ Time Frame: 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.

  5. 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. [ Time Frame: 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.

  6. The immediate success rate of the LBBAP procedure [ Time Frame: 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).

  7. The rate of procedure and Device related complications [ Time Frame: 24 months ]
    Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications.

  8. Changes in Pacing parameters and ECG characteristics. [ Time Frame: 24 months ]
    Pacing parameters include pacing thresholds (ventricle), Sense ampitude (ventricle), Impedance (ventricle). ECG characteristics include paced QRS duration and QRS morphology, etc.

  9. The occurrence of LV dyssynchrony [ Time Frame: 24 months ]
    The occurrence of LV dyssynchrony will be evaluated by echocardiography during 2-year follow-up.

  10. Atrial high-rate episodes recorded by the pacemaker [ Time Frame: 24 months ]
    Atrial high-rate episodes recorded in the pacemaker will be followed during two years of follow-up

  11. The long-term success rate of LBBAP [ Time Frame: 24 months ]
    In LBBAP group, the successful LBBAP will be identified according ECG features at 2-years follow-up


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730921


Contacts
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Contact: Xiaofei Li, M.D. +8617801013995 lixiaofei0103@163.com
Contact: Zhao Wang, M.D. +8618010421619 dream_wangzhao@163.com

Locations
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China, Beijing
Beijing Anzhen hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100029
Contact: Yongquan Wu, M.D.    +8613810751596    wuyongquan67@163.com   
Principal Investigator: Yongquan Wu, M.D.         
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100037
Contact: Zhao Wang, M.D.    01088322405    dream_wangzhao@163.com   
Contact: Xiaohan Fan, Ph.D.    01088322402    fanxiaohan@fuwaihospital.org   
Sub-Investigator: Xiaofei Li, M.D.         
Principal Investigator: Xiaohan Fan, Ph.D.         
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100730
Contact: Taibo Chen, M.D.         
Principal Investigator: Taibo Chen, M.D.         
China, Hebei
The Second Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China
Contact: Ruiqin Xie, M.D.       ruiqin_xie@sina.com   
Principal Investigator: Ruiqin Xie, M.D.         
China, Henan
Fuwai Central China Cardiovascular Hospital Not yet recruiting
Zhengzhou, Henan, China, 450003
Contact: Haitao Yang, M.D.       leoparddoctor1@163.com   
Principal Investigator: Haitao Yang, M.D.         
The First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, Henan, China, 450052
Contact: Chunguang Qiu, M.D.    +860371-66913114    qcg123@163.com   
Principal Investigator: Chunguang Qiu, M.D.         
China, Tianjin
Tianjin Medical University General Hospital Not yet recruiting
Tianjin, Tianjin, China, 300052
Contact: Wenjuan Zhang, M.D.         
Principal Investigator: Wenjuan Zhang, M.D.         
Teda International Cardiovascular Hospital Not yet recruiting
Tianjin, Tianjin, China
Contact: Wenhua Lin, M.D.         
Principal Investigator: Wenhua Lin, M.D.         
Sponsors and Collaborators
Fu Wai Hospital, Beijing, China
Beijing Anzhen Hospital
The First Affiliated Hospital of Zhengzhou University
The Second Hospital of Hebei Medical University
Fuwai Central China Cardiovascular Hospital
Tianjin Medical University General Hospital
Teda International Cardiovascular Hospital, Tianjin, China
Peking Union Medical College Hospital
Chinese Society of Cardiology
Investigators
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Study Chair: Xiaohan Fan, PhD. Fuwai Hospital
More Information
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Publications:

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Responsible Party: Fan Xiaohan, Professor, MD, PhD, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT04730921    
Other Study ID Numbers: 2020-1379
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Fan Xiaohan, Chinese Academy of Medical Sciences, Fuwai Hospital:
Atrioventricular Block
Left bundle branch area pacing
Right ventricular pacing
Additional relevant MeSH terms:
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Atrioventricular Block
Heart Diseases
Cardiovascular Diseases
Heart Block
 Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes