Left Bundle Branch Block (LBBB) After IntuityTM

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.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Incidence of NOP-LBBB (new onset of persistent left bundle branch block)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: May 21, 2021
Registry last updated: Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed