NL-OMON54270招募中不适用

A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Transcatheter Aortic Valve Implantation in Female Patients who have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement - RHEIA (Randomized researcH in womEn all comers wIth Aortic stenosis)

Optimapharm Deutschland GmbH (formerly: SSS International Clinical Research GmbH)0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月15日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 80

研究概览入排标准研究者记录与标识符相似试验

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. Female patients with severe aortic stenosis as follows:
•High gradient severe AS (Class I Indication for AVR):
•Jet velocity >= 4.0 m/s
•or mean gradient >= 40 mmHg with AVA <= 1.0 cm2
•or AVA index <= 0.6 cm2/m2
•Low gradient severe AS (Class I/IIa indication of AVR):
•Jet velocity < 4.0 m/s and mean gradient < 40 mmHg and AVA <= 1.0 cm2 and AVA
•index <= 0.6 cm2/m2 with confirmation of severe AS by: mean gradient >=40 mmHg on
•dobutamine stress echocardiography and/or aortic valve calcium score >= 1200 AU
•on non-contrast CT.
•2. Age >= 18 years (for LUMC: >= 70 years)
•3. The study patient has been informed of the nature of the study, agrees to
•its provisions and has provided written informed consent as approved by the
•Institutional Review Board (IRB)/Ethics Committee (EC) of the respective
•clinical site.

排除标准

•1. Patient is not a candidate for both surgical and transcatheter aortic valve
•replacement.
•2. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV
•based on 3D imaging analysis
•3. Iliofemoral vessel characteristics that would preclude safe placement of the
•introducer sheath.
•4. Evidence of an acute myocardial infarction <= 1 month (30 days) before
•randomization
•5. Aortic valve is unicuspid, bicuspid, or is non-calcified
•6. Severe aortic regurgitation (>3+)
•7. Any concomitant valve disease that requires an intervention
•8. Pre-existing mechanical or bioprosthetic valve in any position. (of note,
•mitral ring is not an exclusion).
•9. Complex coronary artery disease:
•- Unprotected left main coronary artery stenosis
•- Syntax score > 32 (in the absence of prior revascularization)
•- Heart Team assessment that optimal revascularization cannot be performed.
•10. Symptomatic carotid or vertebral artery disease or successful treatment of
•carotid stenosis within 30 days before randomization
•11. Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), Thrombocytopenia
•(Plt < 50,000 cell/mL), history of bleeding diathesis or coagulopathy, or
•hypercoagulable states.
•12. Hemodynamic or respiratory instability requiring inotropic support,
•mechanical ventilation or mechanical heart assistance within 30 days before
•randomization
•13. Hypertrophic cardiomyopathy with obstruction (HOCM)
•14. Ventricular dysfunction with LVEF < 30%
•15. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass,
•thrombus or vegetation
•16. Inability to tolerate or condition precluding treatment with anti-
•thrombotic/anticoagulation therapy during or after the valve implant procedure
•17. Stroke or transient ischemic attack (TIA) within 90 days before
•randomization
•18. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula)
•and/or renal replacement therapy
•19. Active bacterial endocarditis within 180 days of randomization
•20. Severe lung disease (FEV1 < 50%) or currently on home oxygen
•21. Severe pulmonary hypertension (e.g., PA systolic pressure >= 2/3 systemic
•22. History of cirrhosis or any active liver disease
•23. Significant abdominal or thoracic aortic disease (such as porcelain aorta,
•aneurysm, severe calcification, aortic coarctation, etc.) that would preclude
•safe passage of the delivery system or cannulation and aortotomy for surgical
•24. Hostile chest or conditions or complications from prior surgery that
•preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal
•chest wall, adhesion of aorta or IMA to sternum, etc.)
•25. Patient refuses blood products
•26. BMI > 50 kg/m2
•27. Estimated life expectancy < 24 months
•28. Absolute contraindications or allergy to iodinated contrast agent that
•cannot be adequately treated with pre-medication
另有 7 项未显示

研究者

发起方

Optimapharm Deutschland GmbH (formerly: SSS International Clinical Research GmbH)

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