REFLECT - Randomize Evaluation of the TriGuard HDH Embolic Deflection Device Reduce the Impact of Cerebral Embolic Lesions after TransCatheter Aortic Valve Implantation
To assess the safety and efficacy of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI.
Heart & Vascular - Structural Heart Trials,
Heart & Vascular
Sameer Gafoor, MD
Key Inclusion Criteria:
- Meets indications for transcatheter aortic valve implantation (TAVI)
- Willing to comply with protocol-specified follow-up evaluations
- Patients undergoing TAVI via trans-axillary, trans-subclavian, or trans-aortic route or patients undergoing TAVI via transapical approach due to friable or mobile atherosclerotic plaque in the aortic arch.
- Pregnant or nursing subjects and those who plan pregnancy in the period of up to 1 year following index procedure.
- 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 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.
- 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.
- 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
- Patients with severe allergy to heparin or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated
- Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months
- Patients with renal failure (estimated Glomerular Filtration Rate [eGFR] <30 mL/min, calculated from serum creatinine by the Cockcroft-Gault formula)
- Patients with hepatic failure (Child-Pugh class C)
- Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin
- Patients presenting with cardiogenic shock at the time of the index procedure
- Patients with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access
- Patients in whom the aortic arch, innominate artery ostium, or proximal innominate artery is heavily calcified, severely atheromatous, or severely tortuous
- Patients with an innominate artery ostium diameter <10 mm or >25 mm
- Patients with a transverse aortic diameter >43 mm
- Patients with anatomic irregularities of the innominate artery that could prevent positioning of the TriGuard upper stabilizer and compromise stability of the device
- Patients with any other condition that would prevent adherence to the TriGuard HDH Instructions for Use
- Patients with contraindication to cerebral MRI
- Patients who have a planned treatment with any other investigational device or procedure during the study period
- 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.s