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Testing the HemoCept device during heart valve replacement for aortic valve stenosis

Checks whether the HemoCept device detects blood volume and heart efficiency changes in valve surgery.

Key facts

Who runs it
HemoCept Inc.
Where
Boulder, United StatesSee the site
Trial code
Registry title
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
Status
Recruiting
People taking part
20 people, planned
Started
29 Apr 2025
Planned end
Sept 2026
Type of study
Observational
Record updated
13 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who need a trans-aortic valve replacement (TAVR) for aortic valve narrowing. It tests whether the HemoCept device can detect changes in blood volume and heart efficiency.

Age
18 to 80 years, including 18 and 80.
Sex
All sexes can join.
Disease stage
Aortic valve stenosis (narrowing of the aortic valve) that needs a trans-aortic valve replacement.

Main reasons for not taking part

  • Being pregnant, breast-feeding, or planning to become pregnant during the study.
  • A history of Long Q-T syndrome (a heart rhythm problem).
  • A history of cardiac channelopathies (inherited heart electrical problems).
  • A history of seizures.

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Subject has a personal medical history that includes:; Long O-T syndrome; Cardiac channelopathies; Seizures
  • Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in United States

  • Boulder HeartBoulder, United StatesContact: Katharine AdkinsTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Testing the HemoCept device during heart valve replacement for aortic valve stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07205341, who can take part
Record updated
13 April 2026