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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04818502
Eligibility Criteria:
Inclusion Criteria:
1. Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.
2. Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits.
3. Patient provides written informed consent prior to any study-specific procedure.
Exclusion Criteria:
1. Patient is in another clinical study that may impact the follow-up or results of this study.
2. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
3. Patient is under the age of 18 or age of legal consent.
4. Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04818502
Study Brief:
Protocol Section:
NCT04818502