NL-OMON46026已完成不适用
A Randomized Evaluation oF the TriGuard* HDH Embolic Deflection Device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation - The REFLECT Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The patient is a male or non-pregnant female *18 years of age
- •2. The patient meets indications for TAVI
- •3. The patient is willing to comply with protocol-specified follow-up evaluations
- •4. The patient 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).
排除标准
- •1. Patients undergoing TAVI via the trans-axillary, trans-subclavian, or trans-aortic route
- •2. Patients undergoing 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 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 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 6 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 12 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 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 mm
- •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 days prior to the TAVI procedure.
研究者
相似试验
已完成
不适用
Safety and Performance Study of Large Hole Vascular Closure Device - Frontier V studyNL-OMON50786Vivasure Medical Ltd2
已完成
不适用
Randomized, two-arm, multicenter study to evaluate the safety and efficacy of Dura Sealant Patch in reducing CSF leakage following elective cranial surgeryNL-OMON52748Polyganics BV, Groningen26
已完成
不适用
PRostate Evaluation for Clinically Important disease: Sampling using Image-guidance Or Not?Prostaatkanker detectieprostatecancerNL-OMON42747Radboud Universitair Medisch Centrum17
已完成
不适用
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure DeviceAandoeningen aan de hartklepCardiac diseaseVascular intervention1001928010003184NL-OMON42594Essential Medical Inc.35
已完成
4 期
A prospective randomised controlled multicentre trial comparing half-dose photodynamic therapy (PDT) with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (CSC).Chronic central serous chorioretinopathy10047060NL-OMON39842niversitair Medisch Centrum119