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Cerebral Protection in Transcatheter Aortic Valve Replacement

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02214277
First Posted: August 12, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Claret Medical
August 8, 2014
August 12, 2014
October 12, 2017
September 2014
June 2016   (Final data collection date for primary outcome measure)
Primary Efficacy Endpoint [ Time Frame: Day 4-7 Post-Procedure ]

Reduction in median total new lesion volume in protected territories between the Imaging Arms (Test and Control Group) as assessed by DW-MRI at Day 4-7 post-procedure.

  • Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-procedural 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.
Same as current
Complete list of historical versions of study NCT02214277 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Primary Safety Endpoint [ Time Frame: 30 Days Post-Procedure ]
Occurrence of all Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days compared to a historical performance goal.
Primary Safety Endpoint [ Time Frame: 30 Days Post-Procedure ]

Occurrence of all Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days compared to a historical performance goal.

  • MACCE are defined as All Death, All Stroke, and Acute Kidney Injury (Class 3).
 
Cerebral Protection in Transcatheter Aortic Valve Replacement
Cerebral Protection in Transcatheter Aortic Valve Replacement - The SENTINEL Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Severe Symptomatic Calcified Native Aortic Valve Stenosis
  • 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
  • Device: TAVR
    Other Name: TAVR: Edwards SAPIEN THV or Edwards SAPIEN XT
  • Experimental: Test Arm
    Intervention: Device: Cerebral Protection System-The SENTINEL System with TAVR
  • Active Comparator: Control Arm
    Intervention: Device: TAVR
  • Safety Arm
    Intervention: Device: Cerebral Protection System-The SENTINEL System with TAVR
Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, Dwyer MG, Jilaihawi H, Virmani R, Anwaruddin S, Thourani VH, Nazif T, Mangner N, Woitek F, Krishnaswamy A, Mick S, Chakravarty T, Nakamura M, McCabe JM, Satler L, Zajarias A, Szeto WY, Svensson L, Alu MC, White RM, Kraemer C, Parhizgar A, Leon MB, Linke A; SENTINEL Trial Investigators. Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2017 Jan 31;69(4):367-377. doi: 10.1016/j.jacc.2016.10.023. Epub 2016 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
363
Not Provided
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02214277
CP-10836
Yes
Not Provided
Not Provided
Claret Medical
Claret Medical
Not Provided
Principal Investigator: Susheel Kodali, MD Columbia University
Principal Investigator: Samir Kapadia, MD The Cleveland Clinic
Claret Medical
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP