Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis
PRESSEVAL
1 other identifier
observational
100
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 28, 2014
May 1, 2014
1.5 years
November 12, 2012
May 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
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 .
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Departement de Cardiologie
Limoges, 87042, France
Departement de Cardiologie
Montpellier, 34295, France
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2012
First Posted
November 15, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 28, 2014
Record last verified: 2014-05