Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization

NCT07224906 — Recruiting, 50 participants, HemoCept Inc.

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Observational Study of the HemoCept Device During Right Heart Catheterization at Boulder Heart

Registry	NCT07224906
Status	Recruiting
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	HemoCept Inc. (Industry)
Conditions	Pulmonary Hypertension, Congestive Heart Failure(CHF), Valve Disease, Heart
Dates	start 2025-12-01, primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2025-11-05, last updated 2026-04-13
Locations	1 site in United States

-Summary

The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.

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+Outcome measures

Primary outcomes

Association between device measurements and Pulmonary Capillary Wedge Pressure [Day 1]: The correlation of HemoCept device measurements to Pulmonary Capillary Wedge Pressure (PCWP) measured during right heart catheterization.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Boulder Heart	Boulder, Colorado	United States	Recruiting