Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
Sponsored by Abbott Medical Devices
About this trial
Last updated a year ago
Study ID
Status
Type
Placebo
Accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the participation requirements?
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.