Brief Title
DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR
Official Title
A Prospective, Single Arm Feasibility Pilot Study to Evaluate the Safety and Performance of the TriGuard™HDH Embolic Deflection Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)
Brief Summary
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands.
Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the
duration of the TAVR procedure.
Detailed Description
Prospective, single center, single arm pilot study enrolling up to 12 patients at a single
investigational site in the netherlands. Patients meeting eligibility criteria for TAVR and
none of the exclusion criteria will be enrolled to receive the Embolic Deflection Device
throughout the duration of the TAVR procedure.
Study Type
Interventional
Primary Outcome
Device performance
Secondary Outcome
Number of new cerebral lesions
Condition
Aortic Valve Stenosis
Intervention
TriGuard™HDH
Study Arms / Comparison Groups
TriGuard™HDH
Description: Patients undergoing TAVR will be treated wIth experimental device TriGuard™HDH
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
12
Start Date
January 2014
Completion Date
September 2014
Primary Completion Date
August 2014
Eligibility Criteria
Inclusion Criteria:
1. The patient must be ≥ 18 years of age.
2. The patient meets indications for transcatheter aortic valve replacement procedure.
3. The patient is willing to comply with 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 been provided written informed consent,
approved by the appropriate Medical Ethics Committee (EC).
Exclusion Criteria:
1. Patients undergoing transcatheter aortic valve replacement 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 creatine kinase and creatine kinase fraction 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 [Estimated
Glomerular Filtration Rate] <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 white
blood cell <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 fluoroscopic visualization due to obesity or other medical reason
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 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.
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 going through unprotected (cerebral embolization) cardiovascular procedure
prior, during or post transcatheter aortic valve replacement procedure, before the
post-procedure diffusion-weighted magnetic resonance imaging evaluation
21. Patients who have a planned treatment with any other investigational device or
procedure during the study period.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pieter Stella, Md., ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT02073851
Organization ID
DEFLECT II
Responsible Party
Sponsor
Study Sponsor
Keystone Heart
Study Sponsor
Pieter Stella, Md., Principal Investigator, UMC Utrecht
Verification Date
August 2015