SMT Embolic Deflection CE Mark Trial DEFLECT I

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Keystone Heart.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Keystone Heart
ClinicalTrials.gov Identifier:
NCT01448421
First received: September 20, 2011
Last updated: October 6, 2011
Last verified: September 2011
  Purpose

This is a research study using the SMT Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).

The TAVR procedure consists in replacing the diseased aortic valve by a new artificial valve. The new valve is put into place using a long, thin tube called a catheter that is inserted into a small incision (cut) in the patient's groin and threaded through his/her arteries up to the heart.

During the TAVR procedure, there is a risk that an abnormal particle (called embolism) could break off from inside the arteries and travel to the brain. The embolism could be made of clumps of blood (clots), air, part of your body tissue, or part of a medical device. If the embolism is carried through the blood to the brain, it could cause a stroke or other neurological (brain) problems. A stroke happens when blood flow to a part of the brain is blocked, causing brain cells to die.

The SMT Embolic Deflection Device has been developed to prevent an embolism from going to the brain and causing a stroke or other brain damage. The device is a wire mesh filter that covers the vessels that carry blood to brain, deflecting any any blood clots or other materials away from the patient's brain and towards the lower body, where they are less likely to cause harm.


Condition Intervention
Aortic Stenosis
Device: SMT Embolic Deflection Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective, Single Arm Feasibility Study to Evaluate the Safety and Performance of the SMT Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)

Resource links provided by NLM:


Further study details as provided by Keystone Heart:

Primary Outcome Measures:
  • Device performance [ Time Frame: During the enrollment procedure, this is a procedure based end-point that will be assessed at the end of the procedure ] [ Designated as safety issue: No ]
    Device ability to perform all following function without adjudicated device malfunction: Ability to access the aortic arch with the delivery catheter; Ability to position the SMT Device to cover all three vessels without obstruction of carotid/cerebral blood flow and without interference to the TAVR procedure.These two outcomes measure will be reviewed and assessed by an independent Angiographic Core Laboratory;Ability to retrieve and remove the SMT device intact (as reported by the Investigator)

  • Incidence of investigational device- and investigational procedure-related serious adverse events [ Time Frame: 30 days follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: January 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcatheter Aortic Valve Replacement (TAVR). Device: SMT Embolic Deflection Device
The SMT Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must be ≥18 years of age.
  2. Patient meets indications for TAVR procedure.
  3. The patient is willing to comply with protocol-specified follow-up evaluations.
  4. The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).

Exclusion Criteria:

  1. Patients undergoing TAVR via the trans-axillary, subclavian, or direct aortic route
  2. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test.
  3. Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (according to definition) or AMI >72 hours preceding the index procedure, in whom CK and CK-MB have not returned to within normal limits at the time of procedure.
  4. Patients who are currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain.
  5. Patients with impaired renal function (estimated Glomerular Filtration Rate [eGFR] <30, calculated from serum creatinine by the Cockcroft-Gault formula)
  6. Patients with a platelet count of <100.000 cells/mm³ or > 700.000 cells/mm³ or a WBC < 3000 cells/mm³ within 7 days prior to index procedure.
  7. Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion.
  8. Patients who have received any organ transplant or are on a waiting list for any organ transplant.
  9. Patients with known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year.
  10. Patients with known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated.
  11. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
  12. Patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 6 months.
  13. Patients presenting with cardiogenic shock.
  14. Patients with severe peripheral arterial disease that precludes 9Fr sheath vascular access.
  15. Patients with documented friable or mobile atherosclerotic plaque in the aortic arch.
  16. Patients with contraindication to cerebral MRI.
  17. Patients who have a planned treatment with any other investigational device or procedure during the study period
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Keystone Heart
ClinicalTrials.gov Identifier: NCT01448421     History of Changes
Other Study ID Numbers: SMT 8005
Study First Received: September 20, 2011
Last Updated: October 6, 2011
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Keystone Heart:
TAVR

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

ClinicalTrials.gov processed this record on April 17, 2014