Recruiting

Hemocept

Sponsor:

HemoCept Inc.

Code:

NCT07205341

Conditions

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07205341

Start date

Apr 29, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Katharine Adkins

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

Locations

Boulder Heart

Recruiting

Boulder, Colorado, United States, 80303

Contacts

Katharine Adkins

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

Principal Investigator:

Jamie Doucet, MD

More Information

Sponsor

HemoCept Inc.

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HemoCept Inc. on 2026-04-13.