Active — Not RecruitingNot Applicable

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

Austria, Belgium, Czechia200 participantsStarted 2021-05-04

Plain-language summary

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.
✓. 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.
✓. Patient provides written informed consent prior to any study-specific procedure.

✕. Patient is in another clinical study that may impact the follow-up or results of this study.
✕. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
✕. Patient is under the age of 18 or age of legal consent.
✕. 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.

Primary Endpoint for MR Elimination at 1 Year

Timeframe: At 1 year

NCT IDNCT04818502

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05-31