NL-OMON54518招募中3 期
Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR-UNLOAD) - TAVR-UNLOAD
Cardiovascular Research Foundation (CRF)0 个研究点目标入组 56 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
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. Age >=18 years
- •2. Heart failure with NYHA class >= 2
- •3. Under appropriate and stable guideline-directed HF therapy for a minimum of
- •1 month prior to randomization. Note: Patients are expected to be on
- •appropriate pharmacologic therapy and if indicated CRT for heart failure. (12,
- •13) Patients with aortic stenosis may not be able to tolerate maximal doses of
- •heart failure medications and no specific guidelines exist for the medical
- •treatment of heart failure in the setting of aortic stenosis. It is expected
- •that the heart failure PI will review the medical therapy and confirm that it
- •is appropriate for the patient*s condition.
- •4. Moderate AS confirmed by the echo core lab. Moderate AS is defined as an
- •aortic valve area (AVA) >1.0 cm2 and <=1.5 cm2 on rest echo or if <=1.0 cm2 at
- •rest and low-flow AS is suspected when the an AVA > 1.0 cm2 with low dose
- •dobutamine stress echo (DSE). Patients with AVA<1.0 cm2 but with an indexed AVA
- •of >0.6 cm2/m2 on either rest or DSE are also eligible. Similarly, patients
- •with AVA >1.5 cm2 but with indexed AVA<0.9 cm2/m2 on either rest of DSE are
- •also eligible.
- •Note: Typically such cases will demonstrate,
- •Mean trans-aortic gradient (MG) >= 20 mmHg and < 40 mmHg at rest and aortic
- •valve area (AVA) > 1.0 cm2 and <=1.5 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6
- •cm2) at rest
- •Mean trans-aortic gradient (MG) >= 20 mmHg and < 40 mmHg and aortic valve area
- •(AVA) <=1.0 cm2 at rest AND MG < 40 mmHg and aortic valve area (AVA)
- •>1.0 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) with low dose dobutamine
- •stress echo (DSE).
- •In atypical cases (for example mean gradient is below 20 mmHg but valve area is
- •consistent with moderate AS or in case of BSA being elevated due to obesity),
- •the final eligibility determination in regards to diagnosis of moderate AS will
- •be made by the echocardiographic core lab.
- •In indeterminate cases calcium score may also be used to assess the presence of
- •moderate AS.
- •5. Left ventricular (LV) ejection fraction (EF) < 50% at rest
- •6. Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3
- •7. Able to provide independent informed consent (i.e., not requiring a legally
- •authorized representative)
排除标准
- •1. LVEF < 20% or persistent need for intravenous inotropic support
- •2. Hospitalization for acute decompensated HF within 2 weeks prior to
- •randomization
- •3. Cardiac resynchronization therapy (CRT) device implantation within 1 month
- •prior to randomization
- •4. Coronary artery revascularization (PCI or CABG) within 1 month prior to
- •randomization
- •5. In need and suitable for revascularization per heart team consensus
- •6. Severe aortic and/or mitral regurgitation
- •7. Congenital unicuspid or congenital bicuspid aortic valve
- •8. Concomitant non-aortic valvular disease with a formal indication for valve
- •surgery per established guidelines (ESC/ACC/AHA)
- •9. Previous aortic valve replacement (mechanical or bioprosthetic)
- •10. Severe RV dysfunction
- •11. Previous stroke with permanent disability (modified Rankin score >= 2)
- •12. Severe lung disease as indicated by FEV1 <30% predicted or need for chronic
- •daytime supplemental oxygen therapy
- •13. Severe chronic kidney disease: glomerular filtration rate (GFR) < 30 mL/min
- •by MDRD or need for renal replacement therapy
- •14. Gastrointestinal (GI) bleeding within the past 3 months
- •15. Liver cirrhosis Child-Pugh C
- •16. Active systemic infection, including active endocarditis
- •17. Unwilling to accept blood transfusion
- •18. Evidence of intracardiac mass, thrombus or vegetation
- •19. Absence of minimum amount of aortic valve calcification necessary for TAVR
- •with the SAPIEN 3 or SAPIEN 3 Ultra THV
- •20. Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral
- •anticoagulation if indicated (e.g. subject in atrial fibrillation)
- •21. Sensitivity to contrast media which cannot be adequately pre-medicated
- •22. Women of child-bearing potential
- •23. Clinical signs of dementia
- •24. Other medical, social, or psychological conditions that precludes
- •appropriate consent and follow-up
- •25. Life expectancy < 2 years due to cancer or other non-cardiac chronic
- •26. Unwillingness to undergo follow-up investigations
- •27. Currently participating in an investigational drug or another device trial
- •that has not reached its primary endpoint (excluding registries)
研究者
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