Aortic Valve Stenosis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
HemoCept Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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: * Long O-T syndrome * Cardiac channelopathies * Seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of HemoCept device measurements with aortic valve pressure gradient changes. | Perioperative; immediately before procedure, and up to 24 hours after the procedure | 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. |
Countries
United States
Contacts
CONTACTKatharine Adkins
PRINCIPAL_INVESTIGATORJamie Doucet, MD
Boulder Heart
Outcome results
None listed