To demonstrate that the Cerebral Embolic Protection Device (TriGUARD*3) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) leads to less brain injury as assessed by transcranial Doppler measurements.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
* High-intensity transient signals detected by transcranial Doppler (TCD),
during the procedure.
Secondary outcome
Secondary Performance Endpoints:
* Successful device deployment, defined as ability to access the aortic arch
with the TriGUARD* 3 delivery catheter and deploy the device from the
delivery catheter into the aortic arch.
* Successful Device positioning, defined as ability to position the
TriGUARD* 3 device in the aortic arch to cover all major cerebral arteries
* Successful device retrieval, defined as ability to retrieve the TriGUARD* 3
device and remove the intact delivery system
* Device success, defined as successful device deployment, successful
device positioning, complete 3-vessel coverage throughout the procedure,
and successful device retrieval.
Secondary Safety Endpoints
* Cardiovascular mortality
* Ischemic stroke
o Disabling
o Non-disabling
* Life threatening (or disabling) bleeding
* Acute kidney injury (Stage 3)
* Major vascular complications (excluding TAVI access site-related
complications)
Mortality:
* All-cause mortality
o Cardiovascular mortality
o Non-cardiovascular mortality
Stroke (VARC-2 defined), sub-classified as ischemic and hemorrhagic
* All stroke
* Transient ischemic attack (TIA)
Bleeding Complications:
* Life-threatening bleeding (VARC-2)
* Major bleeding related to TriGUARD 3
Acute Kidney Injury (AKI Classification):
Vascular Complications:
* Major vascular complications related to TriGUARD 3
* Major vascular complications related to TAVI
Background summary
The high incidence of strokes, new embolic lesions and the increased neurologic
deficits associated with TAVI indicated a need for improved prevention from any
brain damage. Addressing these neurological complications is necessary to
optimize outcomes and fully realize the potential of TAVI to treat patients
with severe and potentially intermediate and moderate Aortic Stenosis.
Prior designs of Keystone TriGuard cerebral embolic protection devices have
shown significant clinical benefits especially in patients with full coverage
of all three cerebral branches. The TriGUARD* 3 device is a technological
advancement of the TriGuard cerebral embolic protection family. The performance
of the TriGUARD* 3 should be improved through better coverage of all three
cerebral branches in the majority of TAVI patients by increasing the surface
area of the frame and allowing it to conform to the anatomy. The deployment
and positioning of the TriGUARD* 3 is now anatomy independent due to the
elimination of the lower and upper stabilizers. In addition, by eliminating the
upper and lower stabilizers and designing it to self-position, the TriGUARD* 3
should have improved safety since it will be able to position with minimal
manipulation, reduce/eliminate interaction with calcification in the innominate
artery, and deploy consistently in the desired location. The current study is
designed to assess the proof of concept of the next generation TriGUARD*
3 device.
TriGUARD* 3 embolic protection device is a new generation device that is
designed to be an improvement in ease of use and extent of coverage over the
current CE-mark TriGuard* HDH. The TriGuard HDH device and the TriGUARD* 3
device share the same basic principles of operation and intended use and are
manufactured under the same Quality System. Design changes between the TriGuard
HDH and TriGUARD* 3 are expected to improve device safety, effectiveness,
performance, and ease of use.
Study objective
To demonstrate that the Cerebral Embolic Protection Device (TriGUARD*3) in
patients undergoing Transcatheter Aortic Valve Implantation (TAVI) leads to
less brain injury as assessed by transcranial Doppler measurements.
Study design
Prospective, single center, randomized study enrolling up to 30 patients at a
single investigational site in the Netherlands. Patients meeting eligibility
criteria for TAVI and none of the exclusion criteria will be enrolled to
receive either the Embolic Protection Device throughout the duration of the
TAVI procedure or the standard care (1:1 randomization).
Intervention
Standard of care TAVI procedure, during the procedure the Triguard 3 protection
device will be placed.
Study burden and risks
The potential foreseeable risks and discomforts that may be specifically
associated with the study device or procedure and any known or expected
occurrence rate are explained below. There may be other risks that are not yet
known.
* Allergic reaction to nitinol
* Dissection of the innominate artery by improper manipulations, disruption or
migration of the TriGUARD 3 device due to passage of other instrumentation,
e.g.: balloon, valve, catheter, wire.
* Blue toe syndrome or blue discoloration of a toe
* Femoral bleeding at the access site
* Local trauma to the aortic wall due to the TriGUARD 3 migration
* Livedo reticularis of a mottled skin pattern or a lace-like purplish
discoloration of the lower extremities
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Listed location countries
Age
Inclusion criteria
1. The patient must be * 18 years of age.
2. The patient meets indications for TAVI procedure.
3. The patient has been informed of the nature of the study, agrees to its
provisions and has been provided written informed consent, approved by the
appropriate Medical Ethics Committee (EC)
4. The patient is willing to comply with specified follow-up evaluations.
Exclusion criteria
1.Patients undergoing TAVI via the trans-axillary, transapical, subclavian, or
direct aortic route
2 Patients with impaired renal function (estimated Glomerular Filtration Rate
[eGFR] <30, calculated from serum creatinine by the Cockcroft-Gault formula).
3.Patients with a history of a stroke or transient ischemic attack (TIA) within
the prior 6 months.
4.Patients with severe peripheral arterial disease that precludes the delivery
sheath vascular access.
5.Patients who have a planned treatment with any other investigational device
or procedure during the study period.
6.Patients planned to undergo any other cardiac surgical or interventional
procedure during the TAVI procedure (e.g., concurrent coronary
revascularization or within 10 days prior to the TAVI procedure. NOTE:
Diagnostic cardiac catheterization is permitted within 10 days prior to the
TAVI procedure.
7 Patients who have closed temporal window(s).
8. Patients with scheduled valve-in-valve procedure
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70891.100.19 |