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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01727310
First received: November 12, 2012
Last updated: May 24, 2014
Last verified: May 2014

November 12, 2012
May 24, 2014
November 2012
May 2014   (final data collection date for primary outcome measure)
quality of echocardiography [ Designated as safety issue: No ]
Evaluate the diagnostic quality of echocardiography to measure the volume of the LA indexed to body surface area compared to cardiac catheterization
Same as current
Complete list of historical versions of study NCT01727310 on ClinicalTrials.gov Archive Site
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Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis
Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis: Study of Echocardiographic Parameters Compared to Invasive Evaluation

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.
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Observational
Observational Model: Case-Only
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Non-Probability Sample

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 .

Valvular Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01727310
I10013
No
University Hospital, Limoges
University Hospital, Limoges
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University Hospital, Limoges
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP