The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

Launched by KEYSTONE HEART · Aug 27, 2015

Keywords

ClinConnect Summary

This prospective, single-blind, three arm, randomized, (2 device: 1 control), multicenter safety and efficacy trial is designed to enroll up to 603 total subjects in two consecutive phases: Phase I enrolled 258 subjects (including 54 Roll-Ins) and utilized the TriGuard HDH and Phase II will enroll up to 345 subjects (including 40-50 Roll-Ins) and will utilize the TriGUARD 3 (Figure 3b shows the patient flow/disposition).

Phase I In phase I, a total of 204 evaluable subjects and 54 roll-in subjects were enrolled at 26 total investigational sites in the United States, Europe, and Israel, of ...

Gender

ALL

Eligibility criteria

• Subjects must meet ALL of the following criteria:
• • General Inclusion Criteria
• • 1. The patient is a male or non-pregnant female ≥18 years of age
• • 2. The patient meets indications for transcatheter aortic valve implantation (TAVI)
• • 3. The patient is willing to comply with protocol-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 provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).
• Potential Subjects will be excluded if ANY of the following criteria apply:
• • General Exclusion Criteria
• • 1. Patients undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
• • 2. Patients undergoing transcatheter aortic valve implantation (TAVI) via the transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch
• • 3. Patients with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve transcatheter aortic valve implantation (TAVI))
• • 4. 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 14 days prior to index procedure per site standard test
• • 5. 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, in whom Creatine Kinase (CK) and CK-MB have not returned to within normal limits at the time of procedure, or patients who are currently experiencing clinical symptoms consistent with new-onset AMI, such as nitrate-unresponsive prolonged chest pain
• • 6. Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months
• • 7. Patients with known mental or physical 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
• • 8. Patients with severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated
• • 9. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months
• • 10. Patients with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min, calculated from serum creatinine by the Cockcroft-Gault formula)
• • 11. Patients with hepatic failure (Child-Pugh class C)
• • 12. Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin
• • 13. Patients presenting with cardiogenic shock at the time of the index procedure
• • 14. Patients with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access
• • 15. Patients in whom the aortic arch, innominate artery ostium, or proximal innominate artery is heavily calcified, severely atheromatous, or severely tortuous
• • 16. Patients with an innominate artery ostium diameter \<10 mm or \>25 mm
• • 17. Patients with a transverse aortic diameter \>43
• • 18. Patients with anatomic irregularities of the innominate artery that could prevent positioning of the TriGuard upper stabilizer and compromise stability of the device
• • 19. Patients with any other condition that would prevent adherence to the TriGuard HDH Instructions for Use
• • 20. Patients with contraindication to cerebral MRI
• • 21. Patients who have a planned treatment with any other investigational device or procedure during the study period
• • 22. Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVI procedure or within 10 days prior to the TAVI procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 day prior to the TAVI procedure