Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis
Conditions
Interventions
Intervention1: Transcatheter Aortic Valve
Implant: TAVR procedure with ACURATE neo2™ Transfemoral Valve System, with or without the use of SENTINEL™ Cerebral Protection System.
Control Intervention1:
Sponsors
Boston Scientific India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject should be greater than 65 years of age. 2.Subject (or legal guardian) understands the study requirements and procedure, and provides written informed consent, and is willing to comply with all protocol-required follow-up evaluations. 3.Subject is clinically indicated for TAVR to treat symptomatic severe aortic stenosis with the ACURATE neo2TM Transfemoral Aortic Valve System according to the approved indication. 4.For subjects intended to use the SENTINELTM Cerebral Protection System in TAVR procedure, the diameters of subject’s left common carotid artery and brachiocephalic artery must be compatible with the SENTINELTM System.
Exclusion criteria
Exclusion criteria: 1.Subject has any of the contraindications listed in the IFU of study devices. 2.Subject had carotid stenting or carotid endarterectomy within the past 2 months. 3.Subject is currently enrolled in another investigational drug or device clinical trial that would directly interfere with this study. 4.Subject has known hypersensitivity or contraindications to contrast agent that, in the opinion of the investigator, cannot be adequately pre-medicated. 5.Subject has known hypersensitivity/allergy to the study device or protocol related therapies. 6.Subject has any medical condition that, in the opinion of the investigator, is not suitable to use the study devices. 7.Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on assessment of the investigator at the time of enrollment. 8.Subject is unable or not willing to complete follow-up visits and examinations including telephonic follow-ups for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality through 30 days post index procedure Occurrence of major adverse events MAE, defined as a composite of all cause death, all stroke, transient ischemic attack TIA, major vascular complications, major and life-threatening bleeding events and acute kidney injury (stage 2 - 3) at 72 hours post procedure or hospital discharge (whichever comes first), per VARC-2 definitions and adjudicated by Clinical Event Committee (CEC) (for the SENTINEL subgroup) Timepoint: 30 Dyas Psot Index Procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints based on the VARC 2 endpoints & definitions will be collected peri & post procedure at discharge or 7 days post procedure whichever comes first 30 days 6 months & 12 months post index procedure unless otherwise specified below Safety endpoints adjudicated by an independent CEC Mean aortic valve pressure gradient at 30 days post index procedure as measured by transthoracic echocardiography TTE ACURATE Device Performance endpoints peri & post procedure ACURATE Device success Additional indications of prosthetic aortic valve performance. NYHA functional classification. SENTINEL Procedural Success SENTINEL deployment time for the SENTINEL subgroup Timepoint: Peri Post procedure at discharge 30days 6Months 12 Month | — |
Countries
India
Contacts
Public ContactPrashant Janbandhu
Boston Scientific India
Outcome results
None listed