IRB Study Number 22-1120
Status Recruiting
Phase Phase 4
Locations Cleveland Clinic Main Campus, J Building - Sydell & Arnold Miller Family Pavilion
Institute Heart and Vascular Institute
Description
The purpose of this study is to monitor ongoing safety and performance of the commercially available Corcym devices used to treat aortic valve diseases. All the devices are approved by the Food and Drug Administration (FDA).
Study Follow-up: following discharge, you will be asked to return to the hospital at 30 days, 12 months and annually up to 10 years after your heart valve treatment. The assessments performed during these visits are following standard of care. Data to be collected may include: Vital Signs, Blood Test, ECG results, Echocardiography data, blood thinning medications, Clinical Assessment
Inclusion Criteria
- Willing and able to comply with the follow up schedule of the protocol
- Eligible for treatment with Corcym aortic products as outlined
- Signed and dated approved Informed Consent
Exclusion Criteria
- Already participating to another clinical investigation that could confound the results of this clinical investigation
- Has a life expectancy ≤ 12 months
- Has contraindications to the use of the device.
