Evaluation of a new device for monitoring cardiac function
Cardiac Performance System Data Collection Study
Sensydia Corporation · NCT05866666
This study is testing a new device that helps monitor heart function in patients getting heart procedures to see how well it works and if it's safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Sensydia Corporation (industry) |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT05866666 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the performance of a new cardiac performance monitoring device in patients referred for cardiac catheterization. Participants will be monitored for various cardiac conditions, including heart failure and pulmonary hypertension. The study will involve collecting data on the device's effectiveness and safety during routine clinical procedures. It is designed for individuals aged 22 and older who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who are referred for cardiac catheterization due to conditions like heart failure or valvular disease.
Not a fit: Patients who have had a heart transplant or have a left ventricular assist device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of cardiac diseases, enhancing patient outcomes.
How similar studies have performed: While this approach is based on previous iterations of cardiac monitoring devices, the specific evaluation of this new device is novel.
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
Orlando, Florida
- Orlando Health — Orlando, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Yahaira Ortiz-Gonzalez, MD — Orlando Health
- 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.
Conditions: Cardiac Disease