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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04505384
Other study ID # ZS-LBBPvsBVP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date December 31, 2021

Study information

Verified date January 2022
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 31, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - NYHA class II-IV; - LVEF <=35%; - LBBB with QRS duration >=130ms. Exclusion Criteria: - moderate-to-severe aortic stenosis; - frequent premature ventricular complexes; - signi?cant peripheral vascular disease.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
left bundle branch pacing
left bundle branch pacing
biventricular pacing
biventricular pacing

Locations

Country Name City State
China 180 Fenglin Road Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemodynamic parameter LV dP/dt(max) LV dP/dt(max) will be obtained during implant procedure. 1 hour
Secondary Electrical synchrony parameters including QRS duration and QRS area Acquired from EP system during procedure 0.5 hour
Secondary Mechanical parameters including Ts-SD and IVMD Acquired by an echocardiologist during procedure 0.5 hour
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