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Left Bundle Branch Block (LBBB) After IntuityTM

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Completed
CT.gov ID
NCT04897659
Collaborator
(none)
274
Enrollment
1
Location
3.9
Actual Duration (Months)
69.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    274 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve Replacement: Incidence, Long-term Prognostic and Predictive Factors
    Actual Study Start Date :
    Jan 1, 2021
    Actual Primary Completion Date :
    Apr 1, 2021
    Actual Study Completion Date :
    May 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assistance Publique Hôpitaux de Marseille Marseille France 13005

    Sponsors and Collaborators

    • Assistance Publique Hopitaux De Marseille

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique Hopitaux De Marseille
    ClinicalTrials.gov Identifier:
    NCT04897659
    Other Study ID Numbers:
    • CIL 2019-48 bis
    First Posted:
    May 21, 2021
    Last Update Posted:
    Jun 2, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aortic Valve Disease
    Bundle-Branch Block

    Study Results

    No Results Posted as of Jun 2, 2021