Acute Effects of LBBP Versus BVP for CRT

January 19, 2022 updated by: Shanghai Zhongshan Hospital

Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • 180 Fenglin Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left bundle branch pacing
Procedure: left bundle branch pacing
left bundle branch pacing
Active Comparator: Biventricular pacing
Procedure: biventricular pacing
biventricular pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic parameter LV dP/dt(max)
Time Frame: 1 hour
LV dP/dt(max) will be obtained during implant procedure.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrical synchrony parameters including QRS duration and QRS area
Time Frame: 0.5 hour
Acquired from EP system during procedure
0.5 hour
Mechanical parameters including Ts-SD and IVMD
Time Frame: 0.5 hour
Acquired by an echocardiologist during procedure
0.5 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Chair: Yangang Su, MD, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-LBBPvsBVP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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