Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02255851
NCT02255851CompletedNot Applicable

Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement

Claret Medical0 sites300 target enrollmentStarted: March 2014Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
300
Primary Endpoint
Primary Observational Endpoint
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.

Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.

All Sentinel filters will be sent for histopathology at an independent core-lab.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Approved indications for commercially available CE-Marked TAVR devices.
  • •Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%).
  • •The subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective site.

Exclusion Criteria

  • •Vasculature in the right extremity precluding 6Fr sheath radial/brachial access
  • •Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse
  • •Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
  • •Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
  • •Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion
  • •Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
  • •Currently participating in an investigational drug or investigational (non CE-mark) device study

Outcomes

Primary Outcomes

Primary Observational Endpoint

Time Frame: Post-Procedure (day 1)

Capture rate, debris volume and histopathology analysis at day 1.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Claret Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Unknown
Not Applicable
Angel® Catheter Post Market RegistryCatheter ThrombosisMedical Device ComplicationCatheter-related Bloodstream Infection (CRBSI) NosPulmonary EmbolismDeep Vein Thrombosis
NCT02917135BiO2 Medical2,000
Unknown
Not Applicable
Italian Multi-center Registry of Self-apposing Coronary Stent in Patients With STEMIST Segment Elevation Myocardial Infarction
NCT02979236UOSD Emodinamica Diagnostica e Interventistica250
Withdrawn
Not Applicable
Registry for the Use of HEMOBLAST Bellows in Total Knee ArthroplastyArthroplasty, Replacement, Knee
NCT03772912Biom'Up France SAS
Terminated
Not Applicable
The STAPLE International Post-Market RegistryAorto Iliac AneurysmAortic Aneurysm, Abdominal
NCT01276249Medtronic Cardiovascular108
Completed
Not Applicable
Peripheral Registry of Endovascular Clinical Outcomes "The PRIME Registry"Peripheral Vascular DiseaseCritical Limb IschemiaPeripheral Arterial Disease
NCT02786173Metro Health, Michigan1,000