Actively Recruiting
Observational Study of the HemoCept Device During Right Heart Catheterization at Boulder Heart
Led by HemoCept Inc. · Updated on 2026-04-13
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational pilot study aims to collect data from the HemoCept device in patients undergoing diagnostic right heart catheterization procedures. The study focuses on conditions such as pulmonary hypertension, congestive heart failure, and heart valve disease. It is sponsored by HemoCept Inc. and seeks to understand the association between device measurements and pulmonary capillary wedge pressure on the first day of the procedure. Participants will undergo diagnostic right heart catheterization, which may be combined with left heart catheterization, but left-heart-only procedures are not included. This study does not involve any experimental treatments or interventions but focuses on monitoring and collecting data during the catheterization process using the HemoCept device. During the study, participants will be monitored as the device collects data related to heart function. Researchers will assess the device's measurements and compare them to pulmonary capillary wedge pressure to evaluate its performance. The study requires informed consent and HIPAA authorization, with participant involvement mainly centered around the scheduled catheterization procedure and associated data collection.
CONDITIONS
Brief Title
Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- Subject is pregnant, breastfeeding, or intends to become pregnant during this study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 1
Participants undergo diagnostic right heart catheterization with the HemoCept device to collect measurements.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Boulder Heart
Boulder, Colorado, United States, 80303
Actively Recruiting
Research Team
K
Katharine Adkins
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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