SMT Embolic Deflection CE Mark Trial DEFLECT I
Recruitment status was Not yet recruiting
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.
|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)|
- 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 ]
|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)|
|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.