Detecting Changes in Arterial Blood Volume and Cardiac Efficiency

NCT ID: NCT07205341

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-29

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HemoCept Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jamie Doucet, MD

Role: PRINCIPAL_INVESTIGATOR

Boulder Heart

Locations

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Boulder Heart

Boulder, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katharine Adkins

Role: CONTACT

303-442-2395

Facility Contacts

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Katharine Adkins

Role: primary

303-442-2395

Other Identifiers

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PRT-012

Identifier Type: -

Identifier Source: org_study_id

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