DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR

Aortic Valve Stenosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073851
• Other study ID #: DEFLECT II
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: August 26, 2015
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Keystone Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• TriGuard™HDH
TriGuard™HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Keystone Heart

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device performance	Device performance will be evaluated for the following functions: Access the aortic arch, Deploy the TriGuard™HDH from the delivery catheter, Position the TriGuard™HDH to cover the cerebral/carotid vessels, Retrieve the TriGuard™HDH system intact	During TAVR procedure	No
Secondary	Number of new cerebral lesions	The number of new cerebral lesions by diffusion-weighted MRI one week post procedure	one week post procedure	No
Secondary	Volume of new cerebral lesions	The volume of new cerebral lesions by diffusion weighted MRI one week post procedure	One week post procedure	No