NL-OMON51939招募中不适用
VANTAGE Trial: Evaluation of TAVR using the NAVITOR* valve in a global investigation - VANTAGE
Abbott Medical Nederland0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
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. Subject who is judged by a heart team, including a cardiac surgeon, to be
- •appropriate for
- •transcatheter heart valve intervention therapy, and is deemed to be at
- •intermediate or low risk
- •for open surgical aortic valve replacement (i.e., heart team estimates
- •risk of surgical mortality
- •< 7% at 30 days, considering the Society of Thoracic Surgeons (STS)
- •risk score, overall
- •clinical status, and other clinical co-morbidities unmeasured by the
- •risk calculator *)
- •2. New York Heart Association (NYHA) Functional Classification of II, III, or
- •3. Subject is of legal age for consent in the host country
- •4. Subject has been informed of the nature of the trial, agrees to its
- •provisions and has provided
- •written informed consent as approved by the Ethics Committee (EC) of
- •the respective clinical
- •5. Able and willing to return for required follow-up visits and assessments
- •6. Degenerative aortic valve stenosis with echo-derived criteria, defined as:
- •aortic valve
- •area (AVA) of <= 1.0 cm2 (or indexed EOA <= 0.6 cm2/m2) AND either mean
- •gradient >=40
- •mmHg or peak jet velocity >= 4.0 m/s or doppler velocity index (DVI)
- •<=0.25. The
- •echocardiogram supporting the qualifying AVA baseline measurement must
- •be performed
- •within 90 days prior to informed consent) *
- •7. Aortic annulus diameter of 19*30 mm and ascending aorta diameter of 26-44 mm
- •specified valve size listed in the IFU, as measured by CT (systolic
- •phase) conducted within 12
- •months prior to informed consent.
- •* Criterion not applicable for valve-in-valve cohort
排除标准
- •1. Pregnant or nursing subjects and those who plan pregnancy during the
- •clinical investigation
- •follow-up period. A pregnancy test is required for all women of
- •childbearing potential.
- •2. Need for emergency surgery for any reason
- •3. Life expectancy is less than 2 years in the opinion of the Investigator
- •4. Presence of other anatomic or comorbid conditions, or other medical, social,
- •or psychological
- •conditions that, in the investigator*s opinion, could limit the
- •subject*s ability to participate in the
- •clinical trial or to comply with follow up requirements, or impact the
- •scientific soundness of the
- •clinical trial results
- •5. Incapacitated individuals, defined as persons who are mentally ill, mentally
- •handicapped,
- •individuals with severe dementia or individuals without legal authority
- •6. Individuals who are unable to read or write
- •7. Currently participating in an investigational drug or device study that has
- •not reached the
- •primary endpoint or may confound the results of this trial
- •8. Evidence of an acute myocardial infarction [defined as:ST-segment elevation
- •infarction (STEMI) or non-ST-segment elevation myocardial infarction
- •(NSTEMI) with acute
- •ischemia symptoms and troponin elevation] within 30 days prior to index
- •9. Untreated clinically significant coronary artery disease requiring
- •revascularization
- •10. Any percutaneous coronary or peripheral interventional procedure performed
- •within 30 days
- •prior (except pacemaker or implantable cardioverter defibrillator (ICD)
- •implant) to index
- •procedure or planned within 30 days following the index procedure.
- •11. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb <
- •thrombocytopenia (platelet count <50,000 cells/mm³); history of
- •bleeding diathesis or
- •coagulopathy
- •12. Refuses blood products
- •13. Cardiogenic shock manifested by low cardiac output, vasopressor dependence,
- •or mechanical
- •hemodynamic support
- •14. Hemodynamic instability requiring inotropic support or mechanical heart
- •15. Hypertrophic cardiomyopathy with obstruction
- •16. Active peptic ulcer or upper GI bleeding within 3 months prior to index
- •procedure that would
- •preclude anti-coagulation
- •17. Known intolerance, hypersensitivity, or contraindication, including
- •subjects that meet any of the
- •following conditions:
- •a. Subjects who cannot take any antiplatelets or anticoagulants #,
- •b. Subjects who have sensitivity to contrast media which cannot be adequately
- •premedicated,
- 另有 14 项未显示
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