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:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT01112566
Eligibility Criteria:
Inclusion Criteria:
* Indicated for a surgical repair for moderate to severe mitral valve regurgitation at rest (level 2 or higher);
* Willing to return to the hospital where the implantation originally occurred as part of the standard practice of care
Exclusion Criteria:
* Heavily calcified valves
* Valvular retraction with severely reduced mobility
* Active bacterial endocarditis
* Already participating in another investigational device study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints;
* Life expectancy of less than one year;
* Pregnant or desire to be pregnant within 12 months of the study treatment;
* Under 18 years or over 85 years of age.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01112566
Study Brief:
Protocol Section:
NCT01112566