Observational Study: Detecting Changes in Blood Volume and Heart Efficiency for Aortic Valve Stenosis

This observational study is looking at how well a device called HemoCept can detect changes in the amount of blood in your arteries (arterial blood volume) and how efficiently your heart is working (cardiac efficiency). The study aims to see if measurements from the HemoCept device correlate with changes in the pressure across your aortic valve. You may be able to join if you are between 18 and 80 years old, are receiving treatment at a participating healthcare facility, and need a trans-aortic valve replacement. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will be watching and collecting information without giving any specific treatments. It plans to include 20 participants.
What's involved
Measurements will be taken immediately before your procedure and up to 24 hours after your procedure.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken up to 24 hours after your procedure.

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NCT07205341

Detecting Changes in Arterial Blood Volume and Cardiac Efficiency

Recruiting
Not specifiedAges 18–80Observational
HemoCept Inc.
~20 participants
Updated 2026-04-13 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation of HemoCept device measurements with aortic valve pressure gradient changes.
Measured over Perioperative; immediately before procedure, and up to 24 hours after the procedure
Aortic Valve Stenosis
1 sites across 1 states
Colorado1
  • Jamie Doucet, MD · PRINCIPAL_INVESTIGATOR · Boulder Heart

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Eligibility criteria

Inclusion

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 is able and willing to provide informed consent and HIPM authorization.
Subject is able and willing to meet all study requirements.

Exclusion

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
  • 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.