REPRISE China - Clinical Evaluation in China
REPRISE China - Clinical Evaluation in China
To evaluate the safety and effectiveness of the Lotus Edge™ Valve System for transcatheter
 aortic valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native
 aortic stenosis who are considered at high risk for surgical valve replacement.
1. A independent Clinical Events Committee (CEC) will adjudge the safety endpoint.

 2. Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's
 assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review
 Committee [CRC]).

 3. Monitor will review the source data regularly to compare the EDC to ensure the data
 entry can be accuracy, completeness, or representativeness.

 4. Will recruit maximum 62 subjects in maximum 6 sites

 5. Boston Scientific's Standard Operating Procedures to address operations and analysis
 activities, such as patient recruitment, data collection, data management, data
 analysis, reporting for adverse events, and change management.
Inclusion Criteria:

 -  Age ≥ 70 years.

 -  Subject has documented calcific, severe native aortic stenosis with an initial AVA of
 <1.0 cm2 (or AVA index of <0.6 cm2/m2), and a mean pressure gradient ≥40 mm Hg or jet
 velocity ≥4.0 m/s or doppler velocity index ≤0.25, as measured by echocardiography
 and/or invasive hemodynamics.

 -  Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the
 center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case
 Review Committee [CRC]).

 -  Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II.

 -  There is agreement by the heart team (which must include a site investigator
 interventionalist and a site investigator cardiac surgeon) that subject is at high
 operative risk for surgical valve replacement (see note below for definition of high
 risk, the required level of surgical assessment, and CRC confirmation) and that TAVR
 is appropriate. Additionally, subject has at least one of the following.

 -  Society of Thoracic Surgeons (STS) score ≥ 8% -OR-

 -  If STS < 8%, subject has at least one of the following conditions:

 -  Hostile chest

 -  Porcelain aorta

 -  Severe pulmonary hypertension (> 60 mmHg)

 -  Prior chest radiation therapy

 -  Coronary artery bypass graft(s) at risk with re-operation

 -  Severe lung disease (need for supplemental oxygen, FEV1 < 50% of predicted,
 DLCO < 60%, or other evidence of severe pulmonary dysfunction)

 -  Neuromuscular disease that creates risk for mechanical ventilation or
 rehabilitation after surgical aortic valve replacement

 -  Orthopedic disease that creates risk for rehabilitation after surgical
 aortic valve replacement

 -  Childs Class A or B liver disease (subjects with Childs Class C disease are
 not eligible for inclusion in this trial)

 -  Frailty as indicated by at least one of the following: 5-meter walk > 6
 seconds, Katz ADL score of 3/6 or less, body mass index < 21, wheelchair
 bound, unable to live independently

 -  Age ≥ 90 years

 -  Other evidence that subject is at high risk for surgical valve replacement
 (CRC must confirm agreement with site heart team that subject meets high
 risk definition)

 -  Heart team (which must include a cardiac interventionalist and an experienced cardiac
 surgeon) assessment that the subject is likely to benefit from valve replacement.

 -  Subject (or legal representative) understands the study requirements and the treatment
 procedures, and provides written informed consent

 -  Subject, family member, and/or legal representative agree(s) and subject is capable of
 returning to the study hospital for all required scheduled follow up visits.

 Exclusion Criteria:

 -  Subject has a congenital unicuspid aortic valve or Sievers Type 2 bicuspid aortic
 valve.

 -  Subject has had an acute myocardial infarction within 30 days prior to the index
 procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice
 normal in the presence of CK-MB elevation and/or troponin elevation).

 -  Subject has had a cerebrovascular accident or transient ischemic attack within the
 past 6 months prior to study enrollment.

 -  Subject has end-stage renal disease or has serum creatinine > 3mg/dl or has creatinine
 clearance rate <45ml/min.

 -  Subject has a pre-existing prosthetic aortic or mitral valve.

 -  Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.

 -  Subject has a need for emergency surgery for any reason.

 -  Subject has a history of endocarditis within 6 months of index procedure or evidence
 of an active systemic infection or sepsis.

 -  Subject has echocardiographic evidence of new intra-cardiac vegetation or
 intraventricular or paravalvular thrombus requiring intervention.

 -  Subject has platelet count < 50,000 cells/mm3 (50×109/L) or > 700,000 cells/mm3
 (700×109/L), or white blood cell count < 1,000 cells/mm3 (1×109/L).

 -  Subject requires chronic anticoagulation therapy after the implant procedure and
 cannot be treated with warfarin (other anticoagulants are not permitted in the first
 month) for at least 1 month concomitant with either aspirin or clopidogrel.

 -  Subject has had a gastrointestinal bleed requiring hospitalization or transfusion
 within the past 3 months, or has other clinically significant bleeding diathesis or
 coagulopathy that would preclude treatment with required antiplatelet regimen, or will
 refuse transfusions

 -  Subject has known hypersensitivity to contrast agents that cannot be adequately
 pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors,
 heparin, nickel, tantalum, titanium, or polyurethanes

 -  Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid
 conditions based on the assessment of the investigator at the time of enrollment

 -  Subject has hypertrophic obstructive cardiomyopathy

 -  Subject has any therapeutic invasive cardiac or vascular procedure within 30 days
 prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker
 implantation, which is allowed)

 -  Subject has untreated coronary artery disease, which in the opinion of the treating
 physician is clinically significant and requires revascularization

 -  Subject has severe left ventricular dysfunction with ejection fraction < 20%

 -  Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic
 support or mechanical support devices

 -  Subject has severe vascular disease that would preclude safe access (e.g., aneurysm
 with thrombus that cannot be crossed safely, marked tortuosity, significant narrowing
 of the abdominal aorta, severe unfolding of the thoracic aorta, or symptomatic carotid
 or vertebral disease)

 -  Subject has thick (> 5 mm) protruding or ulcerated atheroma in the aortic arch

 -  Subject has an enlarged ascending aorta with the diameter > 50mm

 -  Subject has arterial access that is not acceptable for the study device delivery
 system as defined in the device Instructions For Use

 -  Subject has current problems with substance abuse (e.g., alcohol, etc.)

 -  Subject is participating in another investigational drug or device study that has not
 reached its primary endpoint

 -  Subject has untreated conduction system disorder (e.g., Type II second degree
 atrioventricular block) that in the opinion of the treating physician is clinically
 significant and requires a pacemaker implantation. Enrollment is permissible after
 permanent pacemaker implantation

 -  Subject has severe incapacitating dementia