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Left Bundle Branch Area Pacing in AVB Patients

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ClinicalTrials.gov Identifier: NCT03851315
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Fan Xiaohan, Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary:
Right ventricular pacing (RVP) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. His bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, Increased pacing threshold might result in the early depletion of the pacemaker, and finally brought on pacemaker replacement, which was one of the major causes of device infection. Pacing the left bundle branch beyond the conduction block site might achieve a low and stable output and narrow QRSd. The investigators were prepared to consecutively include patients with atrioventricular block, divided into the left bundle branch area pacing(LBBAP) group and the conventional right ventricular pacing group. The electrophysiological characteristics of LBBAP and right ventricular pacing were compared with ECG characteristics. The left and right ventricular synchrony and left and right cardiac function were evaluated by 3D ultrasound, and the short-term and long-term safety and efficacy of LBBAP were evaluated.

Condition or disease Intervention/treatment
Atrioventricular Block Left Bundle Branch Area Pacing Device: permanent left bundle branch area pacing

Detailed Description:
This study is intended to be included in Fuwai hospital for admission to the atrioventricular block, with permanent pacemaker implant indications recommended by current guidelines. Patients were assessed for preoperative electrocardiogram, quality of life scores, cardiac function, and left and right ventricular synchrony. Patients were followed up by regular outpatients. The electrocardiogram, quality of life score, echocardiographic function, left and right ventricular synchrony, pacing parameters and pacing ratio were evaluated immediately after surgery, 3 months, 6 months, and 12 months after surgery. At the same time, the left bundle branch area pacing success rate, complications during intraoperative and postoperative follow-up were recorded.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Permanent Left Bundle Branch Area Pacing for Atrioventricular Block
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Group/Cohort Intervention/treatment
LBBAP group
patients received left bundle branch area pacing
Device: permanent left bundle branch area pacing
Implant the pacing lead in the left bundle branch area instead of traditional RV pacing site(septal or apical). Successful LBBAP was defined as the paced QRS morphology of right bundle branch block pattern in lead V1 and QRS duration (QRSd) less than 130ms.

traditional RVP group
Age and sex-matched patients received traditional right ventricular pacing



Primary Outcome Measures :
  1. The synchronization status change at 3 months and 1 year as compared with baseline status. [ Time Frame: 3 months and 1 year ]
    Left ventricualr strain change from baseline to 3 month, from baselin to 1 year post operation.


Secondary Outcome Measures :
  1. Pacing threshold change at 3 months and 1 year as compared with baseline status. [ Time Frame: 3 months and 1 year ]
    The pacing threshold changes between 3-month and baseline status, changes between 1 year and the baseline status.

  2. LBBAP related adverse events at 3 months and 1 year as compared with baseline status. [ Time Frame: 3 months and 1 year ]
    The adverse events includes perforation, acute myocardial infarction, loss of capture, increase of pacing threshold, et al. These events were evaluated at baseline, 3 months and 1 year after the procedure, respectively.

  3. left ventricular ejection fraction change at 3 months and 1 year [ Time Frame: 3 months and 1 year ]
    Left ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.

  4. Right ventricular ejection fraction change at 3 months and 1 year [ Time Frame: 3 months and 1 year ]
    Right ventricular ejection fraction change from baseline to 3 month, from baselin to 1 year post operation.

  5. Left ventricular end systolic diameter change at 3 months and 1 year [ Time Frame: 3 months and 1 year ]
    Left ventricular end systolic diameter change from baseline to 3 month, from baselin to 1 year post operation.

  6. Left ventricular end diastolic diameter change at 3 months and 1 year [ Time Frame: 3 months and 1 year ]
    Left ventricular end diastolic diameter change from baseline to 3 month, from baselin to 1 year post operation.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Consecutive AVB patients with indications for ventricular pacing according to 2013 ESC/EHRA Guidelines. Patients with persistent atrial fibrillation or indications for cardiac resynchronization therapy or implantable cardioverter defibrillator implantation , hypertrophic cardiomyopathy, myocardial amyloidosis, or refused postoperative follow-up were excluded. All patients should sign written informed consent for agreement of the implantation procedure.
Criteria

Inclusion Criteria:

  1. Age over 18 years old;
  2. Atrioventricular block patients with indication for permanent ventricular pacing;
  3. LVEF> 40%;
  4. With informed consent signed

Exclusion Criteria:

  1. Persistent atrial fibrillation;
  2. Moderate or more severe valvular disease;
  3. Hypertrophic cardiomyopathy;
  4. Myocardial amyloidosis;
  5. With indication for CRT or ICD implantation according to the current guideline;
  6. Poor condition of the acoustic window because of emphysema or other reasons;
  7. Patients refused postoperative follow-up.

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): NCT03851315


Locations
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China, Beijing
Fu Wai Hospital Recruiting
BeiJing, Beijing, China, 100037
Contact: Xiaofei Li, Master    17801013995    lixiaofei0103@163.com   
Contact: Xiaohan Fan, MD,PhD    13811421067    fanxiaohan@fuwaihospital.org   
Sponsors and Collaborators
Fu Wai Hospital, Beijing, China

Publications of Results:
Other Publications:
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Responsible Party: Fan Xiaohan, MD., PhD., Professor of Medicine, Deputy Director of Arrhythmia Center in Fuwai hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03851315     History of Changes
Other Study ID Numbers: LBBAP-001
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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
Additional relevant MeSH terms:
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Atrioventricular Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes