Acute Effects of LBBP Versus BVP for CRT

Not Applicable

Completed

• Conditions: Cardiac Resynchronization Therapy; Heart Failure; Cardiac Pacing, Artificial
• Interventions: Procedure: left bundle branch pacing; Procedure: biventricular pacing

• Registration Number: NCT04505384
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Study Start: 2020-09-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Left bundle branch pacing	left bundle branch pacing	Left bundle branch pacing
Biventricular pacing	biventricular pacing	Biventricular pacing

Primary Outcome Measures

Name	Time	Method
Hemodynamic parameter LV dP/dt(max)	1 hour	LV dP/dt(max) will be obtained during implant procedure.

Secondary Outcome Measures

Name	Time	Method
Mechanical parameters including Ts-SD and IVMD	0.5 hour	Acquired by an echocardiologist during procedure
Electrical synchrony parameters including QRS duration and QRS area	0.5 hour	Acquired from EP system during procedure

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, China