Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis (PRESSEVAL)
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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 |
- 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 |
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 .
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| Contact: Dania MOHTY, MD | 0555051316 | dania.mohty@chu-limoges.fr |
| 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 | |
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 15, 2012 |
| 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 June 18, 2013