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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT04954404
Eligibility Criteria:
Inclusion Criteria:
1. Patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (TTE), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient.
2. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
3. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
4. Patients are technical and anatomical eligible for interventions.
Exclusion Criteria:
1. In the judgment of the investigator, subjects are not anatomical eligible for interventions.
2. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
3. Active endocarditis or active rheumatic heart disease.
4. History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
5. Subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., Severe mental illness) or life expectancy is less than one year.
6. Subject has any kind of disorder per investigator's judgement that compromises his/her ability to give written informed consent and/or to comply with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04954404
Study Brief:
Protocol Section:
NCT04954404