NL-OMON48239招募中2 期
Cardiac CT for therapeutic stratification in low gradient presumed severe aortic stenosis with preserved left ventricular ejection fraction - CAPTURE AS
OLVG0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written informed consent
- •2. Echocardiographic severe aortic valve stenosis with aortic valve area <1.0
- •3. Preserved left ventricular ejection fraction (LVEF), defined as LVEF at
- •4. Low mean transvalvular aortic pressure gradiënt (<40 mmHg)
- •5. Age at least 60 years
- •6. Patient has suitable anatomy to allow transcatheter aortic valve implantation
- •7. Patient demonstrates symptoms suspicious of heart failure or severe aortic
- •valve stenosis
排除标准
- •1.Hypersensitivity or contraindication to aspirin, heparin, clopidogrel or
- •sensitivity for contrast media which cannot be adequately pre-medicated
- •2.Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia
- •(platelet count <50,000 cells/mm3), history of bleeding diathesis or
- •coagulopathy
- •3.Concomitant valvular disease, defined as more than moderate aortic valve
- •regurgitation, and/or more than moderate mitral valve regurgitation and/or
- •4.Ongoing sepsis, including active endocarditis
- •5.Symptomatic carotid or vertebral artery disease or successful treatment of
- •carotid stenosis within 6 weeks of inclusion
- •6.Active gastrointestinal (GI) bleeding within the past 3 months
- •7.Subject refuses blood transfustion
- •8.Severe dementia
- •9.Estimated life expectancy of less than 24 months due to associated
- •non-cardiac comorbidities
- •10.Other medical, social, or psychological conditions that in the opinion of
- •the investigator precludes the subject form appropriate consent or adherence to
- •the protocol required follow-up exams
- •11.Reduced LV function (LVEF <50%)
- •12.Native aortic annulus size <18 mm or >30 mm per baseline diagnostic imaging
- •13.sinus of valsalva diameter <25 mm or sinus of valsalva height <15 mm
- •14.Concomitant planned coronary artery bypass graft or additional valve
- •intervention
- •15.Hypertrophic obstructive cardiomyopathy
- •16.Echocardiographic or CT evidence of intracardiac mass, thrombus or vegetation
- •17.Transarterial access not able to accommodate an 18Fr sheath
- •18.Patient not being able to exercise or perform 6 MWT
研究者
相似试验
已完成
不适用
Cardiac computed tomography (CT) for the Assessment of chest Pain and PlaqueCoronary artery diseaseCirculatory SystemHeart diseaseISRCTN52480460lster Hospital (UK)500
招募中
不适用
Feasibility of cardiac computed tomography for assessment of left ventricular hypertrophycardiomyopathyJPRN-UMIN000024277Ehime University Hospital School of Medicine200
已完成
不适用
Coronary Computed Tomographic Angiography for Selective Cardiac CatheterizationCoronary Artery DiseaseNCT01810198MDDX LLC1,631
招募中
不适用
ative Coronary Calcium CT as a Planning Tool for CT Coronary Angiography - Effect on Radiation Dose and Image Quality with Different Acquisition Techniques.coronary artery diseaseDRKS00025244niversitätsklinikum Freiburg400
尚未招募
不适用
Coronary CT Angiography for Improved Assessment of Suspected Acute Coronary Syndrome with Inconclusive Diagnostic Work-upheart attacknon-ST elevation acute coronary syndrome10011082NL-OMON44582Erasmus MC, Universitair Medisch Centrum Rotterdam240