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Clinical Trials/CTRI/2024/10/075223
CTRI/2024/10/075223RecruitingPhase 4

A Post-Market Study of the Use of ACURATE neo2TM Transfemoral Valve System with or without SENTINELâ„¢ Cerebral Protection System in Treating Patients with Symptomatic Severe Aortic Stenosis. ACURATE neo2 and SENTINEL Post Market study

Boston Scientific India10 sites in 1 country30 target enrollmentStarted: October 28, 2024Last updated:
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Trial Snapshot

Phase
Phase 4
Status
Recruiting
Sponsor
Enrollment
30
Locations
10
Primary Endpoint
All cause mortality through 30 days post index procedure
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

NA

Study Design

Study Type
Observational

Eligibility Criteria

Ages
65.00 Year(s) to 99.00 Year(s) (—)
Sex
All

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

  • •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.

Outcomes

Primary Outcomes

All cause mortality through 30 days post index procedure

Time Frame: 30 Dyas Psot 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)

Time Frame: 30 Dyas Psot Index Procedure

Secondary Outcomes

  • 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)

Investigators

Sponsor
Boston Scientific India
Sponsor Class
Other [Medical Device Company]
Responsible Party
Principal Investigator
Principal Investigator

Dr Ashok Seth

Fortis Escorts Heart Institute

Study Sites (10)

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