MitraClip China PMS
MitraClip China PMS
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.
Mitral regurgitation (MR) is the most common heart valve condition in the world. MR occurs
 when the mitral valve does not close properly, allowing blood to leak back into the upper
 chamber of the heart. As a result, the heart may try to pump harder in order to compensate
 for the decrease in blood flow to the rest of the body. Patients with severe MR suffer from
 debilitating symptoms such as shortness of breath, heart palpitations, lightheadedness, and
 fatigue. These patients are at risk of poor quality of life, marked limitation in activity,
 repeated heart failure hospitalizations, and increased mortality. Chronic severe MR is often
 associated with heart failure and can lead to death if left untreated.

 While mitral valve repair or replacement surgery is currently regarded as standard of care,
 many patients with clinically significant MR are at an unacceptable risk of morbidity and
 mortality and are therefore not appropriate surgical candidates. To optimize afterload
 reduction and treatment of fluid load, these patients are often treated with medical
 management (i.e., beta blockers, ACE inhibitors, angiotensin II receptor blockers) which may
 relieve MR symptoms, but does not address the underlying cause of the condition. As a result,
 a significant portion of patients treated medically continue to progress to heart failure and
 experience an increasingly debilitating quality of life. A significant unmet clinical need
 thus exists for the treatment of moderate-to-severe and severe MR in high surgical risk
 patients.

 The MitraClip System has been in clinical use for treatment of significant MR since 2003. The
 MitraClip System received CE (Conformité Européenne) Mark for both DMR and FMR indications in
 March 2008 and was approved by FDA for DMR indication in October 2013 and for FMR indication
 in March 2019. The system is approved for use in more than 102 countries or regions
 worldwide. More than 100,000 patients have undergone the MitraClip procedure worldwide. On
 June 15, 2020, the MitraClip System has been approved for clinical use in China.
Inclusion Criteria:

 1. 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.)

 2. Subject is 18 years-old or above.

 3. Subjects who give consent for study procedure.

 Exclusion Criteria:

 1. Subject cannot tolerate procedural anticoagulation or anti-platelet regimen.

 2. Subject with active endocarditis of mitral valve.

 3. Subject with rheumatic mitral valve disease.

 4. Subject with echocardiographic evidence of intracardiac, IVC or femoral venous
 thrombus.

 5. Subject is unlikely to survive the protocol follow up period of 12-months after device
 implant.

 6. Subject has insufficient or lost ability to maintain their will and rights.

 7. Subject is illiterate.

 8. Pregnant or nursing subjects and those who plan pregnancy during the study follow-up
 period

 9. Subject participates in another clinical study that may impact the follow-up or
 results of this study.