NCT04505384

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

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

July 31, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

July 31, 2020

Last Update Submit

January 19, 2022

Conditions

Heart FailureCardiac Pacing, ArtificialCardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic parameter LV dP/dt(max)

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

    1 hour

Secondary Outcomes (2)

  • Electrical synchrony parameters including QRS duration and QRS area

    0.5 hour

  • Mechanical parameters including Ts-SD and IVMD

    0.5 hour

Study Arms (2)

Left bundle branch pacing

EXPERIMENTAL

Left bundle branch pacing

Procedure: left bundle branch pacing

Biventricular pacing

ACTIVE COMPARATOR

Biventricular pacing

Procedure: biventricular pacing

Interventions

left bundle branch pacingPROCEDURE

left bundle branch pacing

Left bundle branch pacing
biventricular pacingPROCEDURE

biventricular pacing

Biventricular pacing

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

Location

Related Publications (1)

  • 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.

    PMID: 36306335DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Yangang Su, MD

    Shanghai Zhongshan Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 10, 2020

Study Start

September 1, 2020

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)