To demonstrate the safety and performance of the Embolic Deflection Device (TriGuard*HDH) in patients undergoing Transcatheter Aortic Valve Replacement (TAVI).
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this trial are device performance and hierarchical
composite device/investigational procedure-related safety during and
immediately post TAVI procedure. Both endpoints will be evaluated in the
Intention to Treat (ITT) and PP (Per Protocol) population using descriptive
statistics. No formal hypothesis testing will be performed.
Secondary outcome
The secondary endpoint analysis of the number and volume of new cerebral
lesions by diffusion-weighted MRI at 4+2 days (range 2-6 days) will be
evaluated in the PP population.
Background summary
Embolic stroke during TAVI procedures occurs in approximately 5% off all
procedures. Besides this there is also a high number of silent cerebral lesions
detected by DW-MRI ( up to 80%) which could lead to cognitive decline of the
patients later in time. The aim is to reduce both acute stroke but also number
of silent lesions in order to avoid invalidation and early onset dementia.
Study objective
To demonstrate the safety and performance of the Embolic Deflection Device
(TriGuard*HDH) in patients undergoing Transcatheter Aortic Valve Replacement
(TAVI).
Study design
Prospective, single center, single arm pilot study enrolling up to 15 patients
at a single investigational site in the Netherland. Patients meeting
eligibility criteria for TAVI and none of the exclusion criteria will be
enrolled to receive the Embolic Deflection Device throughout the duration of
the TAVI procedure.
Study burden and risks
The known risks for TAVI are applicable, besides the potential of local vessel
damage due to manipulation of the device in the aortic arch and manufacturing
problems of the device which may lead to unforeseen complications. The benefit
would be the prevention of cerebral embolsim during the TAVI procedure.
Caesarea Business Park, POB 3170
Caesarea 3088900
IL
Caesarea Business Park, POB 3170
Caesarea 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 is willing to comply with specified follow-up evaluations.
Exclusion criteria
1. Patients undergoing TAVI 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 and CK and CK-MB have not returned to 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 torturous/unsuitable anatomy as related to major cerebral arteries in the aortic arch that may interfere with device deployment or remain deployed.
7. Patients with a platelet count <100.000 cells/mm³ or >700.000 cells/mm³ or a WBC <3000 cells/mm³ within 7 days prior to index procedure.
8. Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or will refuse transfusion.
9. Patients who have received any organ transplant or are on a waiting list for any organ transplant.
10. Poor anticipetid fluoroscopic visualization due to obesity or other medical reason
The DEFLECT II Trial (1.0) Confidential Keystone Heart Ltd
Page 21 of 57
11. Hypotension requiring iv/ia medication or other therapy such as resuscitation and defibrillation
12. Patients with known other medical illness or known history of substance abusethat may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year.
13. Patients with a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, latex, and/or contrast sensitivity that cannot be adequately pre-medicated.
14. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
15. Patients with an active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
16. Patients presenting with cardiogenic shock.
17. Patients with severe peripheral arterial disease that precludes the delivery sheath vascular access.
18. Patients with severe calcification/atheroma, friable or mobile atherosclerotic plaque in the aortic arch
19. Patients with contraindication to cerebral MRI.
20. Patients who have a planned treatment with any other investigational device or procedure during the study period.
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 | NL45294.041.13 |