Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization

April 9, 2026 updated by: HemoCept Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80303
        • Recruiting
        • Boulder Heart
        • Contact:
        • Principal Investigator:
          • Scott Blois, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects above the age of 18 who meet all inclusion/exclusion criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between device measurements and Pulmonary Capillary Wedge Pressure
Time Frame: Day 1
The correlation of HemoCept device measurements to Pulmonary Capillary Wedge Pressure (PCWP) measured during right heart catheterization.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HemoCept Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 31, 2025

First Submitted That Met QC Criteria

November 3, 2025

First Posted (Actual)

November 5, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRT-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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