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Observational, non-interventional, prospective, open-label, single-center, non-randomized study of a CE-marked medical device used in its intended purpose.
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| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | Detection of elevated filling pressures in mmHG by IA-AW, compared to diagnosis by conventional transthoracic echocardiography (TTE) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 1 |
| Secondary endpoints |
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Inclusion Criteria:
Exclusion Criteria:
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In this trial, 200 patients will be recruited at the Jacques Cartier private hospital, Massy (France).
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| Name | Affiliation | Role |
|---|---|---|
| Laurent FIORINA, MD | RCF@ICPS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud | Massy | 91300 | France |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2024 | May 20, 2026 |
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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)
| Day 1 |
| Prot_000.pdf |