NCT07205341RecruitingNot Applicable
A Pilot Clinical Study to Assess Correlation Between Arterial Blood Volume Status and Cardiac Efficiency, and HemoCept Device Data in Trans-Aortic Valve Replacement (TAVR} Surgery
HemoCept Inc.1 site in 1 country20 target enrollmentStarted: April 29, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Correlation of HemoCept device measurements with aortic valve pressure gradient changes.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Outcomes
Primary Outcomes
Correlation of HemoCept device measurements with aortic valve pressure gradient changes.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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