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CompletedNCT04505384Updated Jan 20, 2022

Acute Effects of LBBP Versus BVP for CRT

An interventional study of left bundle branch pacing and biventricular pacing in Heart Failure, Cardiac Pacing, Artificial and Cardiac Resynchronization Therapy, sponsored by Shanghai Zhongshan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-20.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) \<=35% with left bundle branch block (LBBB).

Read the detailed description

The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.

02

Conditions studied

  • Heart Failure
  • Cardiac Pacing, Artificial
  • Cardiac Resynchronization Therapy

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 25 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • NYHA class II-IV;
  • LVEF \<=35%;
  • LBBB with QRS duration >=130ms.

Exclusion criteria

Exclusion Criteria:

  • moderate-to-severe aortic stenosis;
  • frequent premature ventricular complexes;
  • significant peripheral vascular disease.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Left bundle branch pacing

    Left bundle branch pacing

    Procedure: left bundle branch pacing

  • Active comparator
    Biventricular pacing

    Biventricular pacing

    Procedure: biventricular pacing

Interventions

  • Procedureleft bundle branch pacing

    left bundle branch pacing

  • Procedurebiventricular pacing

    biventricular pacing

06

What researchers measure

Primary outcomes

  1. Hemodynamic parameter LV dP/dt(max)

    LV dP/dt(max) will be obtained during implant procedure.

    Time frame: 1 hour

Secondary outcomes

  1. Electrical synchrony parameters including QRS duration and QRS area

    Acquired from EP system during procedure

    Time frame: 0.5 hour

  2. Mechanical parameters including Ts-SD and IVMD

    Acquired by an echocardiologist during procedure

    Time frame: 0.5 hour

07

Study locations

1 site
  • 180 Fenglin Road
    Shanghai, 200032, China
08

References and documents

Publications

  • Liang Y, Wang J, Gong X, Lu H, Yu Z, Zhang L, Li M, Pan L, Chen X, Cui J, Zhang W, Li R, Zhou X, Huang W, Su Y, Ge J. Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e011181. doi: 10.1161/CIRCEP.122.011181. Epub 2022 Oct 28. PubMed 36306335 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04505384
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Aug 10, 2020
Start date
Sep 1, 2020
Primary completion
Sep 30, 2021
Completion
Dec 31, 2021
Last update
Jan 20, 2022

Study contacts

Yangang Su, MD
study chair · Shanghai Zhongshan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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