Left Bundle Branch Block (LBBB) After IntuityTM

Aortic Valve Disease Clinical Trial

Official title:

Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve Replacement: Incidence, Long-term Prognostic and Predictive Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897659
• Other study ID #: CIL 2019-48 bis
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: May 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Bundle-Branch Block

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of NOP-LBBB (new onset of persistent left bundle branch block)	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.	at 1 year