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PRESSEVAL: Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis

Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT01727310
Collaborator
(none)
100
Enrollment
2
Locations
17.9
Duration (Months)
50
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Left valvular heart disease has become one of the most common heart disease in Western countries. This disease evolve over many years and are characterized by a long phase where the patient is "asymptomatic".

it is characterized by discomfort LV filling may worsen and lead typically to a pressure increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable and may occur at the stage of diastolic or systolic dysfunction.

Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing that it is often very difficult to know if the patient is actually symptomatic. The onset of symptoms sign an intolerance to the increase in LV filling pressures and LA , causing pulmonary hypertension .

Therefore, the study of the level of LV and LA filling pressures , if possible by a noninvasive method, would identify patients apparently asymptomatic even though their condition is advanced.

Pressures filling pressures can be explored by two methods:

  • cardiac catheterization, which is a direct and invasive measurement method

  • echocardiography, which is an indirect measurement method which has the advantage of being non-invasive The goal of this research is to compare the two methods.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Official Title:
    Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis: Study of Echocardiographic Parameters Compared to Invasive Evaluation
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    May 1, 2014
    Actual Study Completion Date :
    May 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. quality of echocardiography []

      Evaluate the diagnostic quality of echocardiography to measure the volume of the LA indexed to body surface area compared to cardiac catheterization

    Eligibility Criteria

    Criteria

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

    • Older than 18 years;

    • Patients hospitalized for a coarctation review, and has received or will be receiving during their stay a complete echocardiography and coronary angiography, and left and right catheterization

    Exclusion Criteria:

    • Pregnant women

    • Patients with a history of valve replacement surgery,

    • Patients with other valvular> grade 2 associated with the coarctation

    • Patients known to have ischemic heart disease or in whom angiography showed significant coronary artery disease;

    • Patients with chronic or paroxysmal atrial fibrillation

    • Patients with a permanently pacemaker

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Departement de Cardiologie Limoges France 87042
    2 Departement de Cardiologie Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Limoges

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Limoges
    ClinicalTrials.gov Identifier:
    NCT01727310
    Other Study ID Numbers:
    • I10013
    First Posted:
    Nov 15, 2012
    Last Update Posted:
    May 28, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Aortic Valve Stenosis

    Study Results

    No Results Posted as of May 28, 2014