NL-OMON40150已完成2 期
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) - DEFLECT II
Keystone Heart0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. The patient must be >= 18 years of age.
- •2. The patient meets indications for TAVI procedure.
- •3. The patient is willing to comply with specified follow-up evaluations.
排除标准
- •1. Patients undergoing TAVI 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 CK and CK-MB 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 [eGFR] <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 WBC <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 anticipetid fluoroscopic visualization due to obesity or other medical reason
- •The DEFLECT II Trial (1.0) Confidential Keystone Heart Ltd
- •Page 21 of 57
- •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 abusethat 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 who have a planned treatment with any other investigational device or procedure during the study period.
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