RecruitingNCT07205341

Detecting Changes in Arterial Blood Volume and Cardiac Efficiency

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


Sponsor

HemoCept Inc.

Enrollment

20 participants

Start Date

Apr 29, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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

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Locations(1)

Boulder Heart

Boulder, Colorado, United States

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NCT07205341


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