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Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy

NCT04110431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-18

No results posted yet for this study

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.

Conditions

Interventions

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).

PROCEDURE

Biventricular pacing

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

Sponsors & Collaborators

  • Fu Wai Hospital, Beijing, China

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Jiangang Zou, MD,Ph.D · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-14
Primary Completion
2021-06-29
Completion
2021-06-29

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110431 on ClinicalTrials.gov