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Chronic Heart FailureLBBP-RESYNCNCT04110431

Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy

A study testing Left bundle branch pacing and Biventricular pacing in people with Chronic Heart Failure, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
Left bundle branch pacing and Biventricular pacing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
14 Nov 2019to 29 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Fu Wai Hospital, Beijing, China

    Beijing

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: Comparison Between Left Bundle Branch Pacing and Biventricular Pacing for Cardiac Resynchronization Therapy in Heart Failure(LBBP-RESYNC)

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.

Read the 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.

Being tested
Left bundle branch pacing, Biventricular pacing
Keywords
cardiac resynchronization therapy, chronic heart failure, left bundle branch pacing, biventricular pacing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left bundle branch pacingProcedure or surgery

    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).

  • Biventricular pacingProcedure or surgery

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

Study groups in NCT04110431
Study groupRoleWhat they receive
LBBP groupExperimentalIn 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.
Receives: Procedure: Left bundle branch pacing
BivP groupActive comparatorIn 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.
Receives: Procedure: Biventricular pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Echocardiography parameters(LVEF,LVESV and LVEDV)

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

    Measured: Baseline; 6-month follow-up

Secondary outcomes (6)

  1. Paced QRS duration

    Paced QRS duration is evaluated postoperative day 1 and 1 months, 3 months and 6 months after implantation.

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

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

    Blood test is performed at each time frame to determine the concentration of NT-proBNP(unit: pg/mL)

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

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

    The higher the classification, the more severe the heart failure symptoms(four levels: I, II, III and IV)

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

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

    Distance that a participant walk within 6 minutes

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

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

    Reflect the effect of heart failure on quality of life, and higher scores represent a worse outcome

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

  6. Incidence of clinical adverse events

    Including date and number of all-cause mortality, heart failure hospitalization, cardiovascular hospitalization and malignant ventricular arrhythmia

    Measured: 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start14 Nov 2019
  3. Primary completion29 Jun 2021
  4. Study completion29 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110431
Sponsor's protocol ID
FirstNanjingMU002
Acronym
LBBP-RESYNC
Status last verified
Mar 2022
First submitted
23 Sep 2019
Last updated
18 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29173611

  • 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.

    PubMed 31322651

  • 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.

    PubMed 26888445

  • 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.

    PubMed 36137670

Questions about this trial

What is this clinical trial studying?

A study testing Left bundle branch pacing and Biventricular pacing in people with Chronic Heart Failure, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Echocardiography parameters(LVEF,LVESV and LVEDV) (time frame: Baseline; 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110431, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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