Testing J-Valve Transfemoral (TF) System for aortic valve regurgitation

Exclusion

• −Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, which cannot be adequately premedicated
• −Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• −Aortic valve stenosis \> moderate\*
• −Severe mitral valve or tricuspid valve regurgitation\*
• −Severe mitral valve or tricuspid valve stenosis\*
• −Active infection, including infective endocarditis
• −Cardiac imaging evidence of cardiac mass, thrombus or vegetation
• −Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
• −Renal insufficiency (eGFR \<30 mL/min/1.73m\^2) or end stage renal disease requiring chronic dialysis
• −Liver disease (cirrhosis of the liver \[Child-Pugh Class B or C\])
• −Blood dyscrasias as defined: leukopenia (WBC \<3000 cells/mcL), thrombocytopenia (platelet count \<50,000 cells/mcL), anemia (hemoglobin \<9 g/dL), history of bleeding diathesis coagulopathy, or hypercoagulable state (unless therapeutically stable)
• −Left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<25% as measured by resting echocardiogram (or by CMR, when performed)\*
• −Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure
• −Acute myocardial infarction within 30 days prior to index procedure
• −PCI within 30 days prior to index procedure
• −Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
• −Previous, or planned, other surgical or interventionalInterventional studyA study where participants are given something to see what happens.Read more → procedures within 30 days before, during, or within 30 days after the index procedure
• −Uncontrolled atrial fibrillation
• −Severe right ventricular (RV) dysfunction\*
• −Pulmonary hypertension (systolic PA pressure \>70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP)
• −Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2
• −Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
• −Cardiogenic shock defined as systolic blood pressure \<90 mmHg in addition to signs of tissue hypoperfusion or the need for vasopressors and/or mechanical hemodynamic support to maintain systolic blood pressure ≥90mmHg
• −Patient requires mechanical circulatory support within 30 days prior to index procedure
• −Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
• −Participation in another investigational study that has not reached its primary endpointPrimary endpointThe single main question the study is designed to answer.Read more →
• −Considered to be part of a vulnerable population
• −As assessed by Imaging Core Laboratory
• −Anatomic Exclusions:
• −Ascending Aortic diameter \>5 cm\*
• −Aortic Annulus Perimeter \<57 mm or \>104 mm\*
• −Inappropriate anatomy for femoral introduction and delivery of the study system
• −Left ventricular end-diastolic diameter (LVEDD) \>75 mm\*
• −Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy\*
• −Congenital univentricle or other condition that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → and/or consulting physician, may constitute an unwarranted surgical risk
• −Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus
• −Abdominal/thoracic aortic aneurysm ≥5.0 cm\*
• −Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
• −Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, or LV-aortic root angle \>80⁰
• −Non-native anatomy in aortic zones 0A \& 0B (aortic valve annulus to the distal margin of the right pulmonary artery); 0C (to innominate) only if deemed unfavorable by the Study ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → Committee
• −As assessed by Imaging Core Laboratory
• −Pregnancy or intent to become pregnant prior to completion of all protocolProtocolThe detailed plan a study must follow.Read more → follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → requirements