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OpenTrials
Completed

NCT Number: NCT04505384

Acute Effects of LBBP Versus BVP for CRT

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).

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Key information

Conditions

Heart Failure Cardiac Pacing, Artificial Cardiac Resynchronization Therapy Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

180 Fenglin Road

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Left bundle branch pacing

Procedure

left bundle branch pacing

Biventricular pacing

Procedure

biventricular pacing

Primary outcomes

  1. Hemodynamic parameter LV dP/dt(max)

    Time frame: 1 hour

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

Secondary outcomes

  1. Electrical synchrony parameters including QRS duration and QRS area

    Time frame: 0.5 hour

    Acquired from EP system during procedure

  2. Mechanical parameters including Ts-SD and IVMD

    Time frame: 0.5 hour

    Acquired by an echocardiologist during procedure

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2020
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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