Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization (NCT07224906) | Clinical Trial Compass
RecruitingNot Applicable
Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization
United States50 participantsStarted 2025-12-01
Plain-language summary
The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an observational study where I'm already scheduled for a right heart catheterization, does participating mean any additional procedures or risks beyond what I'd already be going through?
2This study is measuring how well a device matches up with pulmonary capillary wedge pressure readings from the catheter — can you explain what that means for my specific diagnosis, whether it's pulmonary hypertension, heart failure, or valve disease?
3Because this is observational and not testing a new treatment, will my care or treatment decisions be affected in any way by joining, or will everything proceed exactly as planned regardless?
4What kind of device is being compared to the catheter measurements in this study, and is there any chance the data collected could eventually benefit how my condition is monitored in the future?
5Are there any privacy or data-sharing considerations I should understand about how my catheterization results will be used in this research?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association between device measurements and Pulmonary Capillary Wedge Pressure