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The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation of HemoCept device measurements with aortic valve pressure gradient changes. | The primary endpoint is the ability of the HemoCept device to properly detect changes consistent with aortic valve pressure gradient values, measured by echocardiogram pre and post TAVR procedure. | Perioperative; immediately before procedure, and up to 24 hours after the procedure |
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Inclusion Criteria:
Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
Subjects can be any gender but must be between (and including) the ages of 18 and 80.
Subject ls being treated by the participating healthcare facility .
., Subject requires a trans-aortic valve replacement.
Subject is able and willing to provide informed consent and HIPM authorization.
Subject is able and willing to meet all study requirements.
Exclusion Criteria:
Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
Subject has a personal medical history that includes:
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Subjects will be between 18 and 80 and above who meet all the Inclusion/Exclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharine Adkins | Contact | 303-442-2395 | kathari.adkins@bch.org |
| Name | Affiliation | Role |
|---|---|---|
| Jamie Doucet, MD | Boulder Heart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boulder Heart | Recruiting | Boulder | Colorado | 80303 | United States |
There is not a plan to make IPD available
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D014694 |
| Ventricular Outflow Obstruction |