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临床试验/NL-OMON52182
NL-OMON52182已完成不适用

A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement - The PROGRESS trial

Edwards Lifesciences LLC0 个研究点目标入组 40 人开始时间: 待定最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
40
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
65 至 99（—）

入选标准

  • •1. 65 years of age or older at time of randomization
  • •2. Moderate AS per one of the following as assessed by the Echo Core Lab:
  • •A: Aortic valve area (AVA) / Aortic valve area index (AVAi):
  • •AVA 1.0 - 1.5 cm2; OR
  • •AVA < 1.0 with AVAi > 0.6 cm2/m2 if BMI < 30 kg/m2; OR
  • •AVA < 1.0 with AVAi > 0.5 cm2/m2 if BMI >= 30 kg/m2, OR
  • •AVA > 1.5 with AVAi < 0.9 cm2/m2 if BMI < 30 kg/m2; OR
  • •AVA > 1.5 with AVAi < 0.8 cm2/m2 if BMI >= 30 kg/m2
  • •Peak velocity 3.0 - < 4.0 m/s OR mean gradient 20 - < 40 mmHg
  • •B: Subjects who only meet one of the criteria in 2A on resting echo due to
  • •reduced LVEF (< 50%) are eligible if both criteria are met following dobutamine
  • •stress echo (DSE).
  • •Subjects with moderate-severe discordance following DSE are eligible if
  • •non-contrast CT calcium score is < 1200 AU for women or < 2000 AU for men.
  • •Note: Subjects with mild-moderate discordance following DSE are not eligible.
  • •C: Subjects who only meet one of the criteria in 2A on resting echo with
  • •moderate-severe discordance and normal LVEF (>= 50%) are eligible if
  • •non-contrast CT calcium score is < 1200 AU for women or < 2000 AU for men.
  • •Note: Subjects who only meet one of the criteria in 2A on resting echo with
  • •mild-moderate discordance and normal LVEF are not eligible.
  • •3. Subject meets at least one of the following criteria:
  • •Valve-related symptoms including New York Heart Association functional class
  • •>= II, dyspnea, angina, dizziness, pre-syncope, or syncope deemed to be related
  • •LVEF < 60% as assessed by the Echo Core Lab
  • •Diastolic dysfunction (>= Grade 2) as assessed by the Echo Core Lab per
  • •American Society of Echocardiography Guidelines (i.e., E/e* > 14, left atrium
  • •volume index > 34 mL/m2, or tricuspid regurgitation velocity < 2.8 m/sec)
  • •Stroke volume index < 35 mL/m2 as assessed by the Echo Core Lab
  • •Persistent atrial fibrillation or any episode of paroxysmal atrial
  • •fibrillation within 6 months of randomization
  • •NT-Pro BNP > 3x normal as assessed by the site
  • •Elevated calcium score as assessed by Computed Tomography (CT) Core Lab (>
  • •1200 AU for female and > 2000 AU for male) (only applicable for subjects
  • •eligible per 2A or 2B above)
  • •4. The subject or subject*s legal representative has been informed of the
  • •nature of the study, agrees to its provisions, and has provided written
  • •informed consent.

排除标准

  • •1. Native aortic annulus size unsuitable for the THV based on computed
  • •tomography angiography (CTA) analysis
  • •2. Anatomical characteristics that would preclude safe transfemoral placement
  • •of the introducer sheath or safe passage of the delivery system
  • •3. Aortic valve is unicuspid or non-calcified
  • •4. Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe
  • •raphe/leaflet calcification as assessed by CT Core Lab
  • •5. Pre-existing mechanical or bioprosthetic aortic valve
  • •6. Severe aortic regurgitation (>3+)
  • •7. Prior balloon aortic valvuloplasty (BAV) to treat severe AS
  • •8. LVEF < 20% as assessed by the Echo Core Lab
  • •9. Left ventricular outflow tract (LVOT) calcification that would increase the
  • •risk of annular rupture or significant paravalvular leak (PVL) post- TAVR
  • •10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  • •11. Coronary or aortic valve anatomy that increases the risk of coronary artery
  • •obstruction post-TAVR
  • •12. Myocardial infarction within 30 days of randomization
  • •13. Hypertrophic cardiomyopathy with sub-valvular obstruction
  • •14. Any concomitant valvular disease requiring surgical or transcatheter
  • •intervention.
  • •15. Significant untreated coronary artery disease requiring revascularization
  • •16. Any surgical or transcatheter procedure within 30 days of randomization
  • •17. Active bacterial endocarditis within 180 days of randomization
  • •18. Stroke or transient ischemic attack (TIA) within 90 days of randomization
  • •19. Symptomatic carotid or vertebral artery disease or successful treatment of
  • •carotid stenosis within 30 days of randomization
  • •20. Severe chronic obstructive pulmonary disease (COPD, Forced Ejection Volume
  • •1 [FEV1] < 50% predicted) or currently on home oxygen
  • •21. Hemodynamic or respiratory instability requiring inotropic or mechanical
  • •support within 30 days of randomization
  • •22. Liver disease (cirrhosis of the liver [Child-Pugh class B or C])
  • •23. Renal insufficiency (estimated Glomerular Filtration Rate [eGFR] < 30
  • •mL/min per the Cockcroft-Gault formula) and/or renal replacement therapy
  • •24. Significant frailty as determined by the Heart Team
  • •25. Leukopenia (White blood cells < 3000 cells/uL), anemia (Hemoglobin < 9
  • •g/dL), thrombocytopenia (platelets < 50,000 cells/uL)
  • •26. Inability to tolerate or condition precluding treatment with antithrombotic
  • •therapy (including single antiplatelet therapy)
  • •27. Hypercoagulable state or other condition that increases risk of thrombosis
  • •28. Absolute contraindications or allergy to iodinated contrast that cannot be
  • •adequately treated with pre-medication
  • •29. Subject refuses blood products
  • •30. Body mass index (BMI) > 50 kg/m2
  • •31. Estimated life expectancy < 24 months
  • •32. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously
  • •diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  • •(as assessed by the Case Review Board)
  • •33. Participating in another drug or device study that has not reached its
  • •primary endpoint
  • •34. Subject considered to be part of a vulnerable population

研究者

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