Detecting Changes in Arterial Blood Volume and Cardiac Efficiency

NCT07205341 | Recruiting

• 1 other identifier: PRT-012
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• Correlation of HemoCept device measurements with aortic valve pressure gradient changes.

  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.

  Perioperative; immediately before procedure, and up to 24 hours after the procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be between 18 and 80 and above who meet all the Inclusion/Exclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HemoCept Inc.: lead

Study Sites (1)

Boulder Heart

Boulder, Colorado, 80303, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jamie Doucet, MD

  Boulder Heart

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine Adkins

CONTACT

303-442-2395; kathari.adkins@bch.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 3, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)