Cerebral Protection in Transcatheter Aortic Valve Replacement

NCT02214277 | Completed Results DMC

• 1 other identifier: CP-10836
• Study Type: interventional
• Target: 363
• Locations: 2 countries
• Sites: 15

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.

Conditions

Severe Symptomatic Calcified Native Aortic Valve Stenosis

Keywords

Embolic Protection; Edwards SAPIEN THV; Edwards SAPIEN XT; TAVR; Transfemoral; Transapical; Heart Valve Diseases; Heart Diseases; TAVI; Aortic Stenosis; Aortic Valve; Transcatheter Heart Valve

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 2-7 Post-Procedure

• Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days

  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%.

  30 Days Post-Procedure

Secondary Outcomes (1)

• Captured Debris Histopathology (Observational)

  Post-procedure

Study Arms (3)

Test Arm

EXPERIMENTAL

Device: Cerebral Protection System-The SENTINEL System with TAVR

Control Arm

ACTIVE COMPARATOR

Device: TAVR

Safety Arm

OTHER

Device: Cerebral Protection System-The SENTINEL System with TAVR

Interventions

Cerebral Protection System-The SENTINEL System with TAVR DEVICE

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.

Also known as: Cerebral Protection System: The SENTINEL System, TAVR Device: Edwards SAPIEN THV or Edwards SAPIEN XT

Safety Arm; Test Arm

TAVR DEVICE

Also known as: TAVR: Edwards SAPIEN THV or Edwards SAPIEN XT

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:
• inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis; or
• 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.
• 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)
• 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).
• 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
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visit
• 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

You may not qualify if:

• General
• Vasculature in the right extremity precluding 6Fr sheath radial or brachial access
• Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
• Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
• Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
• Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+)
• 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)
• Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
• Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy
• Hemodynamic instability requiring inotropic support or mechanical heart assistance.
• Need for emergency surgery for any reason
• Hypertrophic cardiomyopathy with or without obstruction
• Severe ventricular dysfunction with LVEF ≤20%
• Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation

Sponsors & Collaborators

• Claret Medical: lead

Study Sites (15)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, United States

Location

Morton Plant Hospital

Clearwater, Florida, United States

Location

Emory University Hospital

Atlanta, Georgia, United States

Location

Henry Ford Hospital

Detroit, Michigan, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, United States

Location

Columbia University Medical Center

New York, New York, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Location

Weill Cornell Medical Center

New York, New York, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

UT Houston / Memorial Hermann

Houston, Texas, United States

Location

UVA Advanced Cardiac Valve Center

Charlottesville, Virginia, United States

Location

UW Medical Center

Seattle, Washington, United States

Location

Herzzentrum Leipzig - Universitatsklinik

Leipzig, 04289, Germany

Location

Related Publications (1)

• 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.

  PMID: 27815101 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Heart Valve Diseases; Heart Diseases; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Claret Medical

info@claretmedical.com

707-528-9300

Study Officials

• Susheel Kodali, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Samir Kapadia, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 12, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 11, 2018
• Results First Posted: May 11, 2018

Record last verified: 2018-04

Locations

DE (1); US (14)