| Eligibility |
Inclusion Criteria:
1. Male or female, =70 years old.
2. The existence of primary mitral regurgitation of moderate to severe severity or more
was established by transthoracic echocardiogram (TTE) or transesophageal
echocardiography (TEE) within 3 months previous to inclusion.
3. NYHA class II-IV, symptomatic subject.
4. The subject's left ventricular ejection fraction (LVEF) was less than 20% within the
three months preceding to enrolment, as determined by any of the following methods:
echocardiography, left ventriculography, or cardiac magnetic resonance imaging (MRI)
(not visual assessment).
5. Subjects were evaluated for cardiac anatomical fitness for mitral valve repair surgery
as well as suitability for the research device.
6. Subjects were evaluated for femoral access appropriateness and atrial septal puncture
feasibility.
7. Patients who have been assessed as having a high or very high surgical risk by the
cardiac specialists at each clinical trial location. The most important factor in
their decision *Score from the American Association for Thoracic Surgery (STS): 8% for
surgical mitral valve replacement and 8% for surgical mitral valve repair.
STS score of 8% for surgical mitral valve replacement or 6% for surgical mitral valve
repair, or the presence of additional surgical high-risk variables (such as**
significant weakness or the presence of two or more patients).
severe frailty, more than two uncorrectable organ failures, and surgical-related
impairments (history of open heart surgery, extremely severe thoracic deformity, and
so on), with STS ratings based on the website version accessible at the time of
registration.
**According to the 2020 AHA/ACC Guidelines for Valve Management, high risk for mitral
valve surgery is defined by FDA and MVARC criteria.
8. The patient is willing and capable of adhering to the protocol's requirements and data
collecting methods, understands the trial's aim, and freely participates in and signs
the clinical study by himself or a legal guardian. (8) The participant consents
willingly and signs a written informed consent form authorized by the Clinical Trial
Ethics Committee.
Exclusion Criteria:
1. After heart transplantation, mitral valve surgery or mitral valve transcatheter
surgery
2. Acute myocardial infarction within 1 month.
3. Any vascular intervention or surgical procedure within 1 month.
4. The investigator determines that the subject's femoral vein cannot accommodate the
largest size catheter in the test product or an ipsilateral deep vein thrombosis.
5. The subject has a medical condition that would make evaluation of treatment difficult
(e.g., cancer, infection, severe metabolic disease, severe neurological
(5) Have a disease that would make evaluation of treatment difficult (e.g., cancer,
infection, severe metabolic disease, severe neurological lesions affecting cognitive
ability, psychiatric disease, etc.); or special cases that have been evaluated by the local
trial center cardiac team as inappropriate for (4) Surgical studies related to this
clinical trial device. (6) Severe non-mitral valve disease requiring urgent management and
other cardiac surgical procedures.
(7) Severe mitral valve calcification; leaflet anatomy not conducive to mitral valve clip
placement.
(8) Severe pulmonary hypertension (pulmonary artery systolic pressure >90 mmHg as measured
by echocardiography).
(9) Untreated controlled acute pulmonary edema. (10) Severe right heart insufficiency. (11)
Bleeding disorders or disorders of coagulation; or the presence of contraindications to
antithrombotic therapy (12) Active infection requiring current antibiotic therapy (in the
case of transient disease, the patient will not be enrolled until at least 14 days after
discontinuation of antibiotics).
(12) Active infection requiring current antibiotic therapy (in the case of temporary
disease, patients should be off antibiotics for at least 14 days before being enrolled).
Patients must be free of infection prior to treatment and required dental treatment should
be completed at least 21 days prior to treatment.
(13) History of acute peptic ulcer or gastrointestinal bleeding within 2 months.
(14) Untreated severe coronary artery stenosis requiring hemodialysis (15) Ultrasound
showing intracardiac thrombus, bulky mass, or mass. (16) History of infective endocarditis,
rheumatic heart disease. (17) Hemodynamic instability, defined as systolic blood pressure
<90 mmHg without afterload-reducing drugs, uncorrected cardiogenic shock or the use of
intra-aortic balloon counterpulsation. (18) Patients with contraindications to
transesophageal echocardiography (TEE) and contraindications to general anesthesia.
(19) Patients with allergies or contraindications to study devices or surgical drugs that
cannot be adequately managed by medical means (20) Life expectancy <12 months due to
concomitant non-cardiac comorbidities. (21) Subjects are participating in other clinical
trials that have not met the observed endpoints or that would clinically interfere with
this clinical trial (21) An experimental drug or other device study in which the subject is
participating in another clinical trial that has not met the observed endpoint or would
clinically interfere with the study endpoint of this clinical trial. (Note: If a trial
requires extended follow-up of a product that was investigational at the time of the trial
but has since been marketed, the trial should be conducted in a manner that is consistent
with the clinical trial. (Note: If a trial requires extended follow-up of a product that
was investigational at the time of the trial but has since been marketed, the trial is not
considered to be an investigational trial).
(22) Patients who, in the opinion of the investigator, are not suitable for enrollment in
this trial.
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