NCT04110431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 14, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

September 23, 2019

Last Update Submit

March 16, 2022

Conditions

Chronic Heart Failure

Keywords

cardiac resynchronization therapychronic heart failureleft bundle branch pacingbiventricular pacing

Outcome Measures

Primary Outcomes (1)

  • Echocardiography parameters(LVEF,LVESV and LVEDV)

    Changes in LVEF,LVESV and LVEDV between baseline and follow-up

    Baseline; 6-month follow-up

Secondary Outcomes (6)

  • Paced QRS duration

    Postoperative day 1; 1-month,3-month and 6-month follow-upP

  • Changes in concentration of NT-proBNP in blood between baseline and follow-up

    Baseline; 1-month,3-month and 6-month follow-up

  • Changes in New York Heart Association Heart Function Classification between baseline and follow-up

    Baseline; 1-month,3-month and 6-month follow-up

  • Changes in 6-minute Walk Distance between baseline and follow-up

    Baseline; 1-month,3-month and 6-month follow-up

  • Change in Quality Of Life Questionnaire score between baseline and follow-up

    Baseline; 1-month,3-month and 6-month follow-up

  • +1 more secondary outcomes

Study Arms (2)

LBBP group

EXPERIMENTAL

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

BivP group

ACTIVE COMPARATOR

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

Interventions

Left bundle branch pacingPROCEDURE

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).

LBBP group
Biventricular pacingPROCEDURE

Implantation of a LV pacing lead is attempted using the standard-of-care technique first.

BivP group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Fu Wai Hospital, Beijing, China

Beijing, China

Location

Related Publications (4)

  • Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.

    PMID: 29173611BACKGROUND

  • Hou X, Qian Z, Wang Y, Qiu Y, Chen X, Jiang H, Jiang Z, Wu H, Zhao Z, Zhou W, Zou J. Feasibility and cardiac synchrony of permanent left bundle branch pacing through the interventricular septum. Europace. 2019 Nov 1;21(11):1694-1702. doi: 10.1093/europace/euz188.

    PMID: 31322651BACKGROUND

  • Mafi-Rad M, Luermans JG, Blaauw Y, Janssen M, Crijns HJ, Prinzen FW, Vernooy K. Feasibility and Acute Hemodynamic Effect of Left Ventricular Septal Pacing by Transvenous Approach Through the Interventricular Septum. Circ Arrhythm Electrophysiol. 2016 Mar;9(3):e003344. doi: 10.1161/CIRCEP.115.003344.

    PMID: 26888445BACKGROUND

  • Wang Y, Zhu H, Hou X, Wang Z, Zou F, Qian Z, Wei Y, Wang X, Zhang L, Li X, Liu Z, Xue S, Qin C, Zeng J, Li H, Wu H, Ma H, Ellenbogen KA, Gold MR, Fan X, Zou J; LBBP-RESYNC Investigators. Randomized Trial of Left Bundle Branch vs Biventricular Pacing for Cardiac Resynchronization Therapy. J Am Coll Cardiol. 2022 Sep 27;80(13):1205-1216. doi: 10.1016/j.jacc.2022.07.019.

    PMID: 36137670DERIVED

MeSH Terms

Interventions

Cardiac Resynchronization Therapy

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Jiangang Zou, MD,Ph.D

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

October 1, 2019

Study Start

November 14, 2019

Primary Completion

June 29, 2021

Study Completion

June 29, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)