Monitoring cardiac function with a new device in patients undergoing catheterization
Cardiac Performance System Data Collection Study - Minnesota
This study is testing a new device that monitors heart function in patients getting catheterization to see how well it works and keeps them safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Sensydia Corporation Industry-sponsored |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06149143 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the performance of a new device designed to monitor cardiac function in patients referred for cardiac catheterization. Participants will be assessed for their cardiac health using the Cardiac Performance System, which is based on previous device iterations. The study aims to gather data on the device's effectiveness and safety in real-world clinical settings. It includes patients with various cardiac conditions, such as heart failure and valvular disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who are referred for cardiac catheterization due to various cardiac conditions.
Not a fit: Patients who have had a heart transplant or have certain devices like a left ventricular assist device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring and management of cardiac diseases, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using similar monitoring devices for cardiac function, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to provide written informed consent * 22 years of age or older * Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc. Exclusion Criteria: * Previous Heart Transplant * Presence of Left Ventricular Assist Device * Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement * Surgical scars/wounds/bandages/ports at the site of sensor placement
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Sensydia
- Email: info[@]sensydia.com
- Phone: 6618774670
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.