Left Bundle Branch Block (LBBB) After IntuityTM

Completed

• Conditions: Aortic Valve Disease

• Registration Number: NCT04897659
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis.

It was an observational, retrospective and single-center study. Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent RD-AVR with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. Incidence, prognosis and predictive factors of new-onset of persistent LBBB were evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-04-01
• Status Verified: 2021-05
• Study Completion: 2021-05-01
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-21
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• rapid-deployment aortic valve replacement (RD-AVR) with the Edwards Intuity™ bioprosthesis for severe aortic valve stenosis
• between July 2012 and May 2018

Exclusion Criteria

• preoperative permanent pacemaker or defibrillator,
• complete intraventricular conductive disorder defined by a QRS width ≥ 120 ms.
• absence of patient's authorization for anonymous publication of their clinical data for research purposes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of NOP-LBBB (new onset of persistent left bundle branch block)	at 1 year	QRS duration ≥ 120 ms with QS or rS patterns on the V1 lead, a large notched R wave in D1, aVL, V5 and V6 and the absence of Q wave in V5 and V6, according to the recommendations of the American Heart Association. NOP-LBBB was persistence of LBBB on the 12-lead recording electrocardiogram (ECG) at discharge from hospital.

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France