CompletedNot Applicable

MitraClip China PMS

China51 participantsStarted 2021-12-06

Plain-language summary

The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for open-heart surgery. Treatment with the MitraClip device allows patients to undergo a less invasive procedure that can mechanistically reduce MR and allow for improved quality of life. The MitraClip procedure is performed under general anesthesia without the use of a heart-lung machine, with recovery typically lasting two to three days.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects is eligible to receive the MitraClip per the current approved MitraClip System IFU. (If any update or amendment on the IFU, the latest version of IFU shall be followed.)
✓. Subject is 18 years-old or above.
✓. Subjects who give consent for study procedure.

Exclusion criteria

✕. Subject cannot tolerate procedural anticoagulation or anti-platelet regimen.
✕. Subject with active endocarditis of mitral valve.
✕. Subject with rheumatic mitral valve disease.
✕. Subject with echocardiographic evidence of intracardiac, IVC or femoral venous thrombus.
✕. Subject is unlikely to survive the protocol follow up period of 12-months after device implant.
✕. Subject has insufficient or lost ability to maintain their will and rights.
✕. Subject is illiterate.
✕. Pregnant or nursing subjects and those who plan pregnancy during the study follow-up period

What they're measuring

Percentage of Participants With Acute Procedural Success (APS)

Timeframe: Discharge/30days

Percentage of Participants With Freedom From Major Adverse Event (MAE)

Timeframe: 30 days

Trial details

NCT IDNCT04259411

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-29

Results submitted2025-11-11

View on ClinicalTrials.gov More Mitral Regurgitation trials