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临床试验/NL-OMON53699
NL-OMON53699招募中不适用

Evolut* EXPAND TAVR II Pivotal Trial - Evolut* EXPAND TAVR II Pivotal Trial

Medtronic Trading NL BV0 个研究点目标入组 100 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
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

  • •Please see pg 31 and 32 Key inclusion criteria
  • •Prospective subjects must meet all the following inclusion criteria to be
  • •eligible for randomization:
  • •1. Moderate aortic stenosis by TTE as assessed by the ECL:
  • •o AVA > 1.0 and < 1.5 cm2; or
  • •AVA <= 1.0 cm2 with AVAI > 0.6 cm2/m2 if BMI < 30 kg/m2; or
  • •AVA <= 1.0 cm2 with AVAI > 0.5 cm2/m2 if BMI C30 kg/m2
  • •o Max aortic velocity >= 3.0 m/sec and < 4.0 m/sec or mean aortic gradient >=
  • •20.0 mmHg and < 40.0 mmHg
  • •Subjects with low flow (SVI < 35 ml/m)2 and reduced LVEF (<50%), AVA <= 1.0 cm2,
  • •and max aortic velocity >= 3.0 m/sec and < 4.0 m/sec OR mean gradient >= 20 mmHg
  • •and < 40 mmHg can be included if low dose dobutamine stress echo (DSE)
  • •demonstrates all the following:
  • •- SVI >= 35 ml/m2, and
  • •- AVA > 1.0 cm2 and < 1.5 cm2, and
  • •- Mean aortic gradient >= 20.0 mmHg and < 40.0 mmHg OR max aortic velocity >= 3.0
  • •m/sec and < 4.0 m/sec
  • •Subjects with normal flow (SVI >= 35 ml/m)2and preserved LVEF (>= 50%), AVA <= 1.0
  • •cm2 and max aortic velocity >= 3.0 m/sec and < 4.0 m/sec OR mean gradient >= 20
  • •mmHg and < 40 mmHg can be included if aortic valve calcium score is < 1200 AU
  • •for females and < 2000 AU for males.
  • •2.(3) Listed in the CIP version F_18Sept2023 In the Symptoms of AS, defined as:
  • •NYHA > Class II, or
  • •Reduced functional capacity , defined as
  • •o 6MWT < 300 meters118, 119, or
  • •o < 85% of age-sex predicted metabolic equivalents (MET) on exercise tolerance
  • •testing (ETT)109
  • •3. Any of the following:
  • •Documented heart failure event or hospitalization for heart failure within 1
  • •calendar year prior to consent, or
  • •NT-proBNP >= 600 pg/ml (or >= BNP 80 pg/ml), or
  • •Persistent AF or Paroxysmal AF episode within 6 months prior to consent , , or
  • •Elevated aortic valve calcium score (> 1200 AU for females or > 2000 AU for
  • •males) as assessed by the MDCT core lab, or
  • •Any of the following on the qualifying TTE as assessed by the ECL:
  • •o Global longitudinal strain (GLS) <= 16.0% (absolute value), or
  • •o E/e* >= 14.0 (average of medial and lateral velocities), or
  • •o Diastolic dysfunction > Grade II
  • •o LVEF < 60%, or
  • •o Stroke Volume Index < 35 ml/m2
  • •4. Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+
  • •or Evolut FX system
  • •5. The subject and treating physician agree the subject will return for all
  • •required follow-up visits

排除标准

  • •Please see pg 32 and 33 Key exclusion criteria: * If any of the following
  • •exclusion criteria are present, the prospective subject is not eligible for
  • •randomization:
  • •1. Age < 65 years
  • •2. LVEF < 20% by 2-D echo
  • •3. Class I indication for cardiac surgery
  • •4. Contraindication for placement of a bioprosthetic valve
  • •5. Documented history of cardiac amyloidosis
  • •6. A known hypersensitivity or contraindication to any of the following that
  • •cannot be adequately pre-medicated:
  • •Aspirin, heparin, or bivalirudin
  • •Ticlopidine and clopidogrel
  • •Nitinol (titanium or nickel)
  • •Contrast media
  • •7. Blood dyscrasias as defined: leukopenia (WBC < 1000 cells/mm3),
  • •thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding
  • •diathesis or coagulopathy, or hypercoagulable states
  • •8. Ongoing sepsis, including active endocarditis
  • •9. Frailty syndrome per Heart Valve Team assessment
  • •10. Coronary revascularization (percutaneous coronary intervention or coronary
  • •artery bypass graft) within 30 days prior to randomization
  • •11. In need of and suitable for coronary revascularization per Heart Valve Team
  • •12. Chronic obstructive pulmonary disease (GOLD stage 3 or higher)
  • •13. Symptomatic carotid or vertebral artery disease or successful treatment of
  • •carotid stenosis within 70 days of consent
  • •14. Cardiogenic shock manifested by low cardiac output, vasopressor dependence,
  • •or mechanical hemodynamic support
  • •15. Placement of cardiac resynchronization device within 90 days of consent
  • •16. Recent (within 60 days of consent) cerebrovascular accident (CVA) or
  • •transient ischemic attack (TIA)
  • •17. Child-Pugh class C liver cirrhosis
  • •18. Gastrointestinal (GI) bleeding that would preclude anticoagulation
  • •19. Severe dementia (resulting in either inability to provide informed consent
  • •for the trial/procedure, prevents independent lifestyle outside of a chronic
  • •care facility, or will fundamentally complicate rehabilitation from the
  • •procedure or compliance with follow-up visits)
  • •20. Estimated life expectancy of less than 24 months due to associated
  • •non-cardiac co-morbid conditions
  • •21. Other medical, social, or psychological conditions that in the opinion of
  • •the investigator precludes the subject from appropriate consent or adherence to
  • •the protocol required follow-up exams
  • •22. Currently participating in an investigational drug or another device trial
  • •or study (excluding registries)
  • •23. Evidence of an acute myocardial infarction <= 30 days prior to consent
  • •24. Advanced renal impairment (defined as GFR < 30 mL/min) or need for renal
  • •replacement therapy
  • •25. Need for emergency surgery for any reason
  • •26. Subject is pregnant or breast feeding
  • •27. Subject is less than legal age of consent, legally incompetent, unable to
  • •provide his/her own informed consent, or otherwise vulnerable as defined in
  • 另有 11 项未显示

研究者

发起方
Medtronic Trading NL BV

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