The primary objective of the TriGUARD 3 * First in Man trial is to demonstrate the safety and performance of the TriGUARD*3 in patients undergoing TAVI.
ID
Source
Brief title
Condition
- Other condition
- Cardiac valve disorders
Synonym
Health condition
Preventie CVA/TIA bij TAVI
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* 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.
* Device position, defined as ability to position the TriGUARD* 3 device in the
aortic arch to cover all major cerebral arteries, with proper positioning
maintained (verified by angiography) until the following time points:
o Final deployment of the first prosthetic valve
o Final procedure (after any additional post-dilation or additional valve
implantations have been completed, and the TAVI delivery system has been
removed)
Extent of cerebral artery coverage will be reported as:
o Complete (coverage of all 3 cerebral artery branches)
o Partial (coverage of 1 or 2 cerebral artery branches)
o None
* Device interference, defined as interaction of the TriGUARD* 3 device with
the TAVI system leading to:
o Inability to advance or manipulate the TAVI delivery system or valve
prosthesis, OR
o Inability to deploy the TAVI valve prosthesis, OR
o Inability to retrieve the valve prosthesis or delivery system
* Successful device retrieval, defined as ability to retrieve the TriGUARD* 3
device and remove the intact delivery system
Primary Safety Endpoint Analysis
Incidence of investigational device-related and investigational
procedure-related serious adverse events in a composite hierarchical safety
endpoint during and immediately post TAVI (before discharge from the cath lab)
hierarchical safety endpoint.
* Cardiovascular death
* Ischemic stroke
* Life-threatening or disabling bleeding (EXCLUDE TAVI SIDE RELATED)
* Acute kidney injury (stage 2 or 3)
Secondary outcome
* All-cause mortality
* All stroke
o Disabling
o Non-disabling
* Life threatening (or disabling) bleeding
* Acute kidney injury * Stage 2 or 3 (including renal replacement therapy)
* Major vascular complications
MRI results 2-5 days after 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 safety and performance 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
The primary objective of the TriGUARD 3 * First in Man trial is to demonstrate
the safety and performance of the TriGUARD*3 in patients undergoing TAVI.
Study design
The TriGUARD 3 * First in Man trial is a prospective, single center, single arm
feasibility pilot study designed to assess the safety and performance of the
TriGUARD*3 in patients undergoing TAVI procedures. The TriGUARD 3 * First in
Man trial will enroll up to 10 patients in a single investigational site in the
Netherlands. Patients meeting eligibility criteria for TAVI and none of the
exclusion criteria will be enrolled to receive the study device throughout the
duration of the TAVI procedure.
Intervention
Standard of care TAVI procedure, during the procedure the Triguard 3 protection
device will be placed.
Study burden and risks
Not applicable, negligible risks
Halamish St. 15
Caeserea 3088900
IL
Halamish St. 15
Caeserea 3088900
IL
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 with contraindication to cerebral MRI
Design
Recruitment
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 | NL63886.041.17 |