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Clinical Trials/NL-OMON42354
NL-OMON42354
Completed
Not Applicable

Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation * A Randomized Diffusion-Weighted MRI Study (CP-11134) - SENTINEL-L Study

Claret Medical, Inc.0 sites24 target enrollmentTBD
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Conditionssevere headachedizzinessdifficulty in walkingloss of balance and coordinationblurred or double vision.Stroke: inability to move one or more limbs on one side of the bodyinability to understand or formulate speechinability to see one side of the visual fieldsudden10046973

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
severe headache
Sponsor
Claret Medical, Inc.
Enrollment
24
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Severe symptomatic aortic valve stenosis
  • •2\. Compatible anatomy for Sentinel and LV1 Systems:
  • •o Sentinel System: left common carotid artery (6\.5 \* 10 mm) and brachiocephalic artery (9 \* 15 mm) diameters
  • •o LV1 System: left subclavian artery (7\.0 \* 12\.0 mm) diameter
  • •3\. Subject eligible for transfemoral TAVI access with planned implantation of Boston Scientific Lotus Valve System

Exclusion Criteria

  • •1\. Contraindications to TAVI per heart team
  • •2\. Current or recent cerebrovascular accident (stroke, TIA) \<6 months
  • •3\. Transapical, direct aortic or subclavian TAVI access
  • •4\. Carotid stenting or endarterectomy in last 6 weeks
  • •5\. Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant Carotid Endarterectomy / stenting
  • •6\. History of atrial fibrillation (AF) including:
  • •o Persistent AF (defined as continuous AF which is sustained beyond seven days, or lasting greater than 48 hours and less than seven days but necessitating pharmacologic or electrical cardioversion), or
  • •o History of Paroxysmal AF during the previous 30 days. Paroxysmal AF is defined as recurrent AF (\>2 episodes) that terminates spontaneously within 7 days. Episodes of AF of \< 48 hours\* duration that are terminated with electrical or pharmacologic cardioversion are also classified as paroxysmal AF episodes.;7\. Subject with active endocarditis or other systemic infection
  • •8\. Prior aortic valve replacement
  • •9\. Concomitant procedure with TAVI such as CABG, PCI, etc.

Outcomes

Primary Outcomes

Not specified

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