Aortic Valve StenosisNCT07205341
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
An observational study of Aortic Valve Stenosis, run by HemoCept Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2025to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be between 18 and 80 and above who meet all the Inclusion/Exclusion criteria
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boulder Heart
Boulder, Colorado, 80303
Katharine Adkins, 303-442-2395, kathari.adkins@bch.org
Jamie Doucet, MD
About this study
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
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
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative; immediately before procedure, and up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start29 Apr 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HemoCept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamie Doucet, MD, Principal investigator, Boulder Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205341
- Sponsor's protocol ID
- PRT-012
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07205341
- Acronym / sponsor ID
- PRT-012
- Conditions
- Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- HemoCept Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be between 18 and 80 and above who meet all the Inclusion/Exclusion criteria
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
- Subject has a personal medical history that includes:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie Doucet, MD principal investigator
Boulder Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by HemoCept Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katharine Adkins (303-442-2395, kathari.adkins@bch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.