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

Valvular Disease Clinical Trial

— PRESSEVAL  

Official title:

Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis: Study of Echocardiographic Parameters Compared to Invasive Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727310
• Other study ID #: I10013
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: May 24, 2014
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Valvular Disease

Locations

Country	Name	City	State
France	Departement de Cardiologie	Limoges
France	Departement de Cardiologie	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No