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

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01727310
First received: November 12, 2012
Last updated: November 4, 2013
Last verified: November 2013
  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 [ 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


Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727310

Contacts
Contact: Dania MOHTY, MD 0555051316 dania.mohty@chu-limoges.fr

Locations
France
Departement de Cardiologie Recruiting
Limoges, France, 87042
Principal Investigator: Dania MOHTY, MD         
Sub-Investigator: Béndicte TANGUY, MD         
Departement de Cardiologie Recruiting
Montpellier, France, 34295
Contact: Florence LECLERCQ, MD    33 4 67 33 61 88    f-leclercq@chu-montpellier.fr   
Principal Investigator: Florence LECLERCQ, MD         
Sponsors and Collaborators
University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01727310     History of Changes
Other Study ID Numbers: I10013
Study First Received: November 12, 2012
Last Updated: November 4, 2013
Health Authority: France: The Commission nationale de l’informatique et des libertés

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

ClinicalTrials.gov processed this record on April 20, 2014