Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
- Moderate AS, defined as follows by transthoracic echo (TTE) at rest:
- Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec; and
- Mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg; and
- AVA > 1.0 cm^2 and < 1.5 cm^2.
- NYHA class ≥ II and symptoms of AS, including but not limited to:
- Dyspnea at rest or on exertion;
- Fatigue;
- Angina;
- Syncope in the absence of another identifiable cause;
- LVEF > 20% by 2-D echo.
- Any of the following:
- HF event or hospitalization within 1 calendar year prior to qualifying echo;
- NT proBNP ≥ 600 pg/ml (or BNP 80 pg/ml) measured within 6 months prior to or
within 2 weeks after qualifying echo;
- Global longitudinal strain ≤ 15% (absolute value) at qualifying echo; or
- E/e' (average of medial and lateral velocities) ≥ 14.0 at qualifying echo.
Exclusion Criteria:
-Age < 65 years
- Class I indication for cardiac surgery
- Contraindication for placement of a bioprosthetic valve
- Documented history of cardiac amyloidosis
- A known hypersensitivity or contraindication to any of the following that cannot be adequately premedicated:
• Aspirin, heparin, or bivalirudin;
Ticlopidine and clopidogrel;
• Nitinol (titanium or nickel)
• Gold
• Contrast media
- Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3 ), thrombocytopenia (platelet count <50,000 cells/mm^3 ), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- Ongoing sepsis, including active endocarditis
- Frailty syndrome per Heart Valve Team assessment
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft) within 30 days prior to randomizationi
- In need of and suitable for coronary revascularization per Heart Valve Team
- Chronic obstructive pulmonary disease (GOLD stage 3 or higher)
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 70 days of date of qualifying echocardiogram
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- Placement of cardiac resynchronization device within 90 days of qualifying echocardiogram
- Recent (within 60 days of qualifying echocardiogram) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Child-Pugh class C liver cirrhosis
- Gastrointestinal (GI) bleeding that would preclude anticoagulation
- Subject refuses a blood transfusion
- Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
- Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
- Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
- Currently participating in an investigational drug or another device trial or study (excluding registries)
Evidence of an acute myocardial infarction ≤ 30 days before the qualifying echo
- Advanced renal impairment (defined as GFR < 30 mL/min) or need for renal replacement therapy
- Need for emergency surgery for any reason
- Subject is pregnant or breast feeding
- Subject is less than legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable as defined in Section 6.2. Anatomical exclusion criteria:
- Congenital unicuspid valve
- Sievers Type 0 or Type 2 bicuspid aortic valve
- Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm
- Not anatomically suited for transfemoral TAVR with the trial device
- Absence of calcified aortic valve on baseline TTE or MDCT
- Severe LVOT calcification52
- Pre-existing prosthetic heart valve in any position
- Severe mitral regurgitation
- Severe tricuspid regurgitation
- Moderate or severe mitral stenosis (mean gradient ≥ 5 mmHg, or valve area ≤ 1.5 cm^2 )
- Hypertrophic obstructive cardiomyopathy
- Severe basal septal hypertrophy with an outflow gradient
- Severe aortic regurgitation
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/7/23. Questions regarding updates should be directed to the study team contact.