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Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy (LBBP-RESYNC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110431
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Fu Wai Hospital, Beijing, China
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The present study will recruit 40 symptomatic heart failure patients with left ventricular ejection fraction (LVEF) below 35% and complete left bundle branch block(QRSd≥130 ms). Each patient was randomized to either left bundle branch pacing(LBBP) or biventricular pacing(BivP) and was followed up for at least 6 months. The objective is to compare the effects of LBBP and BivP on cardiac resynchronization in the treatment of heart failure by measurable clinical parameters.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Procedure: Left bundle branch pacing Procedure: Biventricular pacing Not Applicable

Detailed Description:

The traditional biventricular pacing (BivP) is an established treatment to corrected the cardiac dyssynchrony in heart failure patients with left bundle branch block(LBBB). It has been proved that BivP can improve clinical symptoms and reduce all-cause mortality in heart failure. However, BivP is subject to the variable coronary sinus(CS) anatomy and LV-pacing lead fail to be implanted in 5%-10% of patients due to the lack of appropriate target branch, high threshold or phrenic nerve stimulation. Almost 30%-40% of patients with successful implantation show no response. What's more, BivP just corrects the mechanical dyssynchrony caused by LBBB not corrects the LBBB. Recent studies have demonstrated that His bundle pacing (HBP) can correct LBBB, achieve physiological pacing and realize the cardiac resynchronization. But HBP has high technical requirements, lower sense value and higher threshold of correcting LBBB, which may be further increased in long-term follow-up.

The lastest research shows that pacing left ventricular septum using a transseptal approach can reduce left ventricular(LV) electrical dyssynchrony. Huang et al first confirmed that left bundle branch pacing(LBBP) can correct LBBB and improve cardiac function. LBBP has been reported to offer higher success rate with higher sense value and lower pacing thresholds compared with HBP. In chronic heart failure patients with LBBB that need cardiac resynchronization therapy(CRT), LBBP can achieve the similar electrical and mechanical resynchronization as well as HBP.

There is to date no randomized studies between LBBP and BivP in HFrEF patients with complete LBBB that need CRT. The purpose of this study is to compare the therapeutic effects of LBBP and conventional BivP on LV function and clinical endpoints in such patients. The present study will randomize 40 patients in two centres to LBBP or BivP. Baseline assessments including echocardiography parameters[left ventricular ejection fraction(LVEF ), left ventricular end-systolic volume(LVESV), left ventricular end-diastolic volume(LVEDV)], electrocardiogram(ECG), N-terminal pro B-type natriuretic peptide(NT-proBNP) level, New York Heart Association(NYHA) class, 6-minute walking distance(6MWD) and quality of life score(QOL) will be obtained. At the same time, the LBBP and BivP success rate, intraoperative and postoperative complications are recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Left Bundle Branch Pacing and Biventricular Pacing for Cardiac Resynchronization Therapy in Heart Failure(LBBP-RESYNC)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: LBBP group
In this arm, An right artrial (RA) lead and an implantable cardioverter defibrillator (ICD) lead are conventionally implanted. A left bundle branch pacing(LBBP) lead is attempted to be placed. If LBBP failed, a left ventricular(LV) pacing lead is implanted instead.
Procedure: Left bundle branch pacing
Successful LBBP was defined as (1) LBBP lead is located at 1.5-2cm from His-bundle towards right ventricular apex; (2) Paced QRS morphology of right bundle branch delay(CRBBD) in lead V1; (3) Stimulus to the peak of R wave in V5 and V6 QRS wave, which represents left ventricular activation time(Stim-LVAT), is less than 100ms and constant at high and low output pacing; (4) Unipolar pacing threshold<1.5V/0.5ms; (5) Recording P potential when narrow QRS escape rhythm or CRBBB escape rhythm(not essential).

Active Comparator: BivP group
In this arm, an RA lead , an ICD lead and a LV pacing lead are placed. If the implantation of LV pacing lead is unsuccessful due to unavailable coronary sinus branches(venae cordis magna or venae cordis media is not recommended), capture above 3.5V/0.5ms or refractory phrenic nerve stimulation,a LBBP lead is placed instead.
Procedure: Biventricular pacing
Implantation of a LV pacing lead is attempted using the standard-of-care technique first.




Primary Outcome Measures :
  1. Echocardiography parameters(LVEF,LVESV and LVEDV) [ Time Frame: Baseline; 6-month follow-up ]
    Changes in LVEF,LVESV and LVEDV between baseline and follow-up


Secondary Outcome Measures :
  1. Paced QRS duration [ Time Frame: Postoperative day 1; 1-month,3-month and 6-month follow-upP ]
    Paced QRS duration is evaluated postoperative day 1 and 1 months, 3 months and 6 months after implantation.

  2. Changes in concentration of NT-proBNP in blood between baseline and follow-up [ Time Frame: Baseline; 1-month,3-month and 6-month follow-up ]
    Blood test is performed at each time frame to determine the concentration of NT-proBNP(unit: pg/mL)

  3. Changes in New York Heart Association Heart Function Classification between baseline and follow-up [ Time Frame: Baseline; 1-month,3-month and 6-month follow-up ]
    The higher the classification, the more severe the heart failure symptoms(four levels: I, II, III and IV)

  4. Changes in 6-minute Walk Distance between baseline and follow-up [ Time Frame: Baseline; 1-month,3-month and 6-month follow-up ]
    Distance that a participant walk within 6 minutes

  5. Change in Quality Of Life Questionnaire score between baseline and follow-up [ Time Frame: Baseline; 1-month,3-month and 6-month follow-up ]
    Reflect the effect of heart failure on quality of life, and higher scores represent a worse outcome

  6. Incidence of clinical adverse events [ Time Frame: 6-month follow-up ]
    Including date and number of all-cause mortality, heart failure hospitalization, cardiovascular hospitalization and malignant ventricular arrhythmia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. LVEF≤35% as assessed by echocardiography and NYHA class II-IV despite optimal medical therapy for at lest 3 months;
  2. Sinus rhythm, complete left bundle branch block (QRS duration ≥130ms);
  3. Between the ages of 18 and 80;
  4. With informed consent signed.

Exclusion Criteria:

  1. After mechanical tricuspid valve replacement;
  2. Unstable angina, acute MI, CABG or PCI within the past 3 months;
  3. Persistent atrial fibrillation without atrioventricular block, the expected percentage of ventricular pacing below 95%;
  4. Enrollment in any other study;
  5. A life expectancy of less than 12 months;
  6. Pregnant or with child-bearing potential;
  7. History of heart transplantation.

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): NCT04110431


Contacts
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Contact: Jiangang Zou, MD,Ph.D 86-13605191407 jgzou@njmu.edu.cn

Locations
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China, Jiangsu
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Contact: Jiangang Zou, MD,Ph.D    86-13605191407    jgzou@njmu.edu.cn   
Principal Investigator: Jiangang Zou, MD,Ph.D         
China
Fu Wai Hospital, Beijing, China
Beijing, China
Contact: Xiaohan Fan, MD,Ph.D         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Fu Wai Hospital, Beijing, China
Investigators
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Principal Investigator: Jiangang Zou, MD,Ph.D The First Affiliated Hospital with Nanjing Medical University
Publications:
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04110431    
Other Study ID Numbers: FirstNanjingMU002
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
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: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
cardiac resynchronization therapy
chronic heart failure
left bundle branch pacing
biventricular pacing
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases