HemoCept device data collection during diagnostic right heart catheterization
Observational Study of the HemoCept Device During Right Heart Catheterization at Boulder Heart
HemoCept Inc. · NCT07224906
This pilot will collect HemoCept device readings from adults having diagnostic right heart catheterization to see how the device records heart pressures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HemoCept Inc. (industry) |
| Locations | 1 site (Boulder, Colorado) |
| Trial ID | NCT07224906 on ClinicalTrials.gov |
What this trial studies
This single-center observational pilot will collect continuous HemoCept device data from adult patients undergoing clinically indicated diagnostic right heart catheterization (RHC) at Boulder Heart. The device will be used during standard-of-care RHC or combined RHC+LHC procedures without altering clinical treatment. Collected device signals and time-synced clinical hemodynamic measurements will be compiled to characterize device performance and data quality. The study will enroll consenting adults aged 18 and older and excludes pregnant or breastfeeding participants.
Who should consider this trial
Good fit: Adults (age 18 or older) who can give informed consent and are scheduled for a diagnostic right heart catheterization at the Boulder Heart site are ideal candidates.
Not a fit: People not undergoing RHC (including those having left-heart-only procedures), those under 18, or pregnant/breastfeeding individuals are not expected to benefit from participation.
Why it matters
Potential benefit: If successful, the device could enable better or more convenient hemodynamic monitoring to help diagnose and manage pulmonary hypertension and heart failure.
How similar studies have performed: Comparable device-validation efforts during RHC have been performed for other hemodynamic monitoring technologies, but peer-reviewed evidence specific to HemoCept is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 age 18 or older. * Subject is able and willing to provide informed consent and HIPAA authorization. * Subject is able and willing to meet all study requirements. * Scheduled for a diagnostic right heart catheterization (RHC-only or combined RHC+LHC; left-heart-only procedures are not eligible) Exclusion Criteria: * Subject is pregnant, breastfeeding, or intends to become pregnant during this study.
Where this trial is running
Boulder, Colorado
- Boulder Heart — Boulder, Colorado, United States (RECRUITING)
Study contacts
- Study coordinator: Katharine Adkins
- Email: kathari.adkins@bch.org
- Phone: 303-442-2395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Hypertension, Congestive Heart Failure, Valve Disease, Heart