Observational, non-interventional, prospective, open-label, single-center, non-randomized study of a CE-marked medical device used in its intended purpose.
Study Type
OBSERVATIONAL
Enrollment
200
Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud
Massy, France
Primary endpoint
Detection of elevated filling pressures in mmHG by IA-AW, compared to diagnosis by conventional transthoracic echocardiography (TTE)
Time frame: Day 1
Secondary endpoints
Comparison of the performance of the IA-AW and IA-12D in detecting elevated filling pressures in mmHG, compared to the diagnosis of conventional transthoracic echocardiography (TTE)
Time frame: Day 1
Secondary endpoints
Classification of filling pressures (elevated, normal, indeterminate) in mmHG by the IA-AW and IA-12D, compared to the diagnosis of conventional transthoracic echocardiography (TTE)
Time frame: Day 1
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