Acute Effects of LBBP Versus BVP for CRT

Shanghai Zhongshan Hospital25 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart Failure Cardiac Pacing, Artificial Cardiac Resynchronization Therapy

Interventions

left bundle branch pacingPROCEDURE

left bundle branch pacing

biventricular pacingPROCEDURE

biventricular pacing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

180 Fenglin Road

Shanghai, China

Outcomes

Primary Outcomes

Hemodynamic parameter LV dP/dt(max)

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

Time frame: 1 hour

Secondary Outcomes

Electrical synchrony parameters including QRS duration and QRS area

Acquired from EP system during procedure

Time frame: 0.5 hour

Mechanical parameters including Ts-SD and IVMD

Acquired by an echocardiologist during procedure

Time frame: 0.5 hour

Data from ClinicalTrials.gov

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