N/A
N=51
MitraClip China PMS
Mitral Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT04259411 ↗Enrolled (actual)
51
Serious AEs
31.4%
Results posted
Dec 2025
Primary outcome: Primary: Percentage of Participants With Acute Procedural Success (APS) — 93.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MitraClip procedure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Acute Procedural Success (APS) |
93.9 | — |
| PRIMARY Percentage of Participants With Freedom From Major Adverse Event (MAE) |
100.0 | — |
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.
Eligibility Criteria
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
- Subject participates in another clinical study that may impact the follow-up or results of this study.
Data sourced from ClinicalTrials.gov (NCT04259411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.