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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

ABT-CIP-10313

Status

Active, not recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Started 4 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status