Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT01137734
Eligibility Criteria:
Inclusion Criteria:
* Patient is a candidate for mitral valve repair.
* Patient able and willing to return to the implant center for follow-up visits.
* Able and willing to give informed consent and follow protocol procedures.
Exclusion Criteria:
* Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
* Evolving endocarditis or active endocarditis in the last 3 months.
* Heavily calcified annulus or leaflets.
* Congenital malformation with limited valvular tissue
* Patient requires mitral valve replacement.
* Previously implanted prosthetic mitral valve or annuloplasty ring/band.
* Patient requires aortic or pulmonic valve replacement or repair.
* Patient is pregnant (urine HCG test result positive) or lactating.
* Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
* Life expectancy of less than twelve months.
* Patient is participating in concomitant research studies of investigational products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01137734
Study Brief:
Protocol Section:
NCT01137734