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Cerebral Protection in Transcatheter Aortic Valve Replacement

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ClinicalTrials.gov Identifier: NCT02214277
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Claret Medical

Study Description
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Brief Summary:
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior circulation.

Condition or disease Intervention/treatment Phase
Severe Symptomatic Calcified Native Aortic Valve Stenosis Device: Cerebral Protection System-The SENTINEL System with TAVR Device: TAVR Not Applicable

Detailed Description:

The Sentinel™ Cerebral Protection System is indicated for use as an embolic capture and retrieval system intended to reduce the ischemic burden in the cerebral anterior circulation while performing transcatheter aortic valve replacement.

The objective of this study is to assess the safety and efficacy of the Claret Medical Sentinel Cerebral Protection System used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR) compared to TAVR standard of care (without embolic protection).

The study population is comprised of subjects with severe symptomatic calcified native aortic valve stenosis who meet the commercially approved indications for TAVR with the Edwards SAPIEN THV or SAPIEN XT and comply with the inclusion/exclusion criteria.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cerebral Protection in Transcatheter Aortic Valve Replacement - The SENTINEL Study
Study Start Date : September 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Test Arm Device: Cerebral Protection System-The SENTINEL System with TAVR
Claret Medical Sentinel Cerebral Protection System is intended for use as an embolic protection system to contain and remove embolic material (thrombus/debris) that may enter the carotid arteries.
Other Names:
  • Cerebral Protection System: The SENTINEL System
  • TAVR Device: Edwards SAPIEN THV or Edwards SAPIEN XT
Active Comparator: Control Arm Device: TAVR
Other Name: TAVR: Edwards SAPIEN THV or Edwards SAPIEN XT
Safety Arm Device: Cerebral Protection System-The SENTINEL System with TAVR
Claret Medical Sentinel Cerebral Protection System is intended for use as an embolic protection system to contain and remove embolic material (thrombus/debris) that may enter the carotid arteries.
Other Names:
  • Cerebral Protection System: The SENTINEL System
  • TAVR Device: Edwards SAPIEN THV or Edwards SAPIEN XT


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure. [ Time Frame: Day 2-7 Post-Procedure ]
    Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.

  2. Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days [ Time Frame: 30 Days Post-Procedure ]
    Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.


Secondary Outcome Measures :
  1. Captured Debris Histopathology (Observational) [ Time Frame: Post-procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Approved indications for commercially available Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX or SAPIEN XT, model 9300TFX meeting one of the three sub-criteria below:

    SAPIEN

    1. transfemoral delivery in subjects with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction >20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to either be:

      1. inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis; or
      2. be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons predicted operative risk score >8% or are judged by the heart team to be at a 15% risk of mortality for surgical aortic valve replacement.

      or

    2. transapical delivery in subjects with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction > 20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons operative risk score 8% or are judged by the heart team to be at a 15% risk of mortality for surgical aortic valve replacement.

      SAPIEN XT (Transfemoral or Transapical only)

    3. in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
  2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%) as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality
  3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visit
  4. The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site

Exclusion Criteria:

General

  1. Vasculature in the right extremity precluding 6Fr sheath radial or brachial access
  2. Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
  3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
  4. Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
  5. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
  6. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+)
  7. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease)
  8. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
  9. Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy
  10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
  11. Need for emergency surgery for any reason
  12. Hypertrophic cardiomyopathy with or without obstruction
  13. Severe ventricular dysfunction with LVEF ≤20%
  14. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
  15. Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant CEA/stenting
  16. Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 weeks
  17. Active peptic ulcer or upper GI bleeding within the prior 3 months
  18. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated
  19. Recent (within 6 months) CVA or a TIA
  20. Renal insufficiency (creatinine > 3.0 mg/dL or GFR < 30) and/or renal replacement therapy at the time of screening
  21. Life expectancy < 12 months due to non-cardiac co-morbid conditions
  22. Subjects in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
  23. Subjects who have active bacterial endocarditis or other active infections
  24. Currently participating in an investigational drug or another device study
  25. Subjects who have a planned treatment with any other investigational device or procedure during the study follow-up period (90 days)
  26. Subject with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation during the study follow-up period (90 days)

  27. Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure

    Neurologic

  28. Subject had active major psychiatric disease
  29. Subject has severe visual, auditory, or learning impairment and who are unable to comprehend English and therefore unable to be consented for the study

  30. Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities

    Angiographic

  31. Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion

  32. Subject whose brachiocephalic or left carotid artery reveals significant stenosis, calcification, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium

    Magnetic Resonance Imaging

  33. Subject Body Mass Index (BMI) precluding imaging in scanner
  34. Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure)
  35. Planned implantation of a pacemaker or defibrillator implantation after TAVR
  36. Claustrophobia
  37. Known allergy to gadolinium or contrast agent
Contacts and Locations
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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): NCT02214277


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States
United States, New York
Columbia University Medical Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
UT Houston / Memorial Hermann
Houston, Texas, United States
United States, Virginia
UVA Advanced Cardiac Valve Center
Charlottesville, Virginia, United States
United States, Washington
UW Medical Center
Seattle, Washington, United States
Germany
Herzzentrum Leipzig - Universitatsklinik
Leipzig, Germany, 04289
Sponsors and Collaborators
Claret Medical
Investigators
Principal Investigator: Susheel Kodali, MD Columbia University
Principal Investigator: Samir Kapadia, MD The Cleveland Clinic
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Claret Medical
ClinicalTrials.gov Identifier: NCT02214277     History of Changes
Other Study ID Numbers: CP-10836
First Posted: August 12, 2014    Key Record Dates
Results First Posted: May 11, 2018
Last Update Posted: May 11, 2018
Last Verified: April 2018

Keywords provided by Claret Medical:
Embolic Protection
Edwards SAPIEN THV
Edwards SAPIEN XT
TAVR
Transfemoral
Transapical
 Heart Valve Diseases
Heart Diseases
TAVI
Aortic Stenosis
Aortic Valve
Transcatheter Heart Valve

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction