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Sentinel(TM) Post-Market Registry

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ClinicalTrials.gov Identifier: NCT02255851
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Claret Medical

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.


Condition or disease Intervention/treatment
Transcatheter Aortic Valve Replacement Severe Symptomatic Calcified Native Aortic Valve Stenosis Device: SENTINEL (Cerebral Protection System)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement
Actual Study Start Date : March 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment Group
TAVR + SENTINEL (Cerebral Protection System)
Device: SENTINEL (Cerebral Protection System)



Primary Outcome Measures :
  1. Primary Observational Endpoint [ Time Frame: Post-Procedure (day 1) ]
    Capture rate, debris volume and histopathology analysis at day 1.


Biospecimen Retention:   Samples With DNA
Capture and histopathology analysis of embolic debris. (Thrombus, valve tissue, amorphous calcium, etc.)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The registry population comprises subjects with severe symptomatic calcified native aortic valve stenosis who are selected for TAVR by heart team consensus and treated with CE-Marked TAVR devices.
Criteria

Inclusion Criteria:

  1. Approved indications for commercially available CE-Marked TAVR devices.
  2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%).
  3. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255851


Sponsors and Collaborators
Claret Medical
Investigators
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Principal Investigator: Christoph Naber, MD Elisabeth-Krankenhaus Essen GmbH, Essen, Germany

Additional Information:

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Responsible Party: Claret Medical
ClinicalTrials.gov Identifier: NCT02255851     History of Changes
Other Study ID Numbers: CP10879
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Keywords provided by Claret Medical:
selected for TAVR by heart team consensus
treated with CE-Marked TAVR devices
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction