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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01727310
First Posted: November 15, 2012
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Limoges
  Purpose

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
Valvular Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: November 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of both gender 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 .
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727310


Locations
France
Departement de Cardiologie
Limoges, France, 87042
Departement de Cardiologie
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Limoges
  More Information

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01727310     History of Changes
Other Study ID Numbers: I10013
First Submitted: November 12, 2012
First Posted: November 15, 2012
Last Update Posted: May 28, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction