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Recruiting

NCT Number: NCT07205341

Detecting Changes in Arterial Blood Volume and Cardiac Efficiency

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.

Recruiting

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boulder Heart

Boulder, Colorado, 80303, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

HemoCept Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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