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OpenTrials
Completed

NCT Number: NCT04149535

PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement

To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash Medical Center, Clayton, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access
  • Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.
  • Subject (or legal representative) provides written informed consent.

Exclusion criteria

  • Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery.
  • Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.
  • Subject has compromised blood flow to the right upper extremity.
  • Subject has access vessels with excessive tortuosity.
  • Subject has uncorrected bleeding disorders.
  • Subject is contraindicated for anticoagulant and antiplatelet therapy.

Treatment and study plan

Sentinel® Cerebral Protection System

Device

cerebral embolic protection system

Primary outcomes

  1. The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)

    Time frame: <=72 hours

    All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

Acronym: PROTECTED TAVR

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 4, 2019
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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