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Clinical Trials/NCT04505384
NCT04505384
Completed
N/A

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

Shanghai Zhongshan Hospital1 site in 1 country25 target enrollmentSeptember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Shanghai Zhongshan Hospital
Enrollment
25
Locations
1
Primary Endpoint
Hemodynamic parameter LV dP/dt(max)
Status
Completed
Last Updated
4 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Hemodynamic parameter LV dP/dt(max)

Time Frame: 1 hour

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

Secondary Outcomes

  • Mechanical parameters including Ts-SD and IVMD(0.5 hour)
  • Electrical synchrony parameters including QRS duration and QRS area(0.5 hour)

Study Sites (1)

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