NCT03471065已完成不适用
A Prospective, Single-arm, Multicenter Study of the SAPIEN 3 Ultra System in Intermediate Risk Patients With Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Edwards Lifesciences7 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2018年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Procedural Success
研究概览
简要总结
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram criteria:
- •Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2
- •Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg
- •New York Heart Association functional class ≥ II
- •Judged by the Heart Team to be at intermediate risk for open surgical therapy
- •The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis
- •Aortic valve is unicuspid, bicuspid or non-calcified
- •Pre-existing mechanical or bioprosthetic valve in any position.
- •Severe aortic regurgitation (> 3+)
- •Severe mitral regurgitation (> 3+) or ≥ moderate stenosis
- •Ventricular dysfunction with left ventricular ejection fraction < 30%
- •Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- •Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
- •Subjects with planned concomitant ablation for atrial fibrillation
- •Hypertrophic cardiomyopathy with obstruction
- •Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
- •Complex coronary artery disease:
- •Unprotected left main coronary artery
- •SYNTAX score > 32
- •Heart Team assessment that optimal revascularization cannot be performed
- •Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath
- •Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
- •Active bacterial endocarditis within 180 days of the valve implant procedure
- •Stroke or transient ischemic attack within 90 days of the valve implant procedure
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure
- •Severe lung disease (Forced Ejection Volume 1 < 50% predicted) or currently on home oxygen
- •Severe pulmonary hypertension
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure
- •History of cirrhosis or any active liver disease
- •Renal insufficiency and/or renal replacement therapy at the time of screening
- •Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- •Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
- •Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- •Significant frailty as determined by the Heart Team
- •Subject refuses blood products
- •Body mass index > 50 kg/m2
- •Estimated life expectancy < 24 months
- •Positive urine or serum pregnancy test in female subjects of childbearing potential
- •Currently participating in an investigational drug or another device study.
结局指标
主要结局
Procedural Success
时间窗: Day 0
The number of patients with procedural success, defined as freedom from all of the following at exit from the procedure room: * Mortality * Conversion to surgery * Moderate or severe paravalvular regurgitation
次要结局
- Major Vascular Complications(Discharge, expected to be within 1-5 days post-procedure])
- Valve Migration or Embolization(Discharge, expected to be within 1-5 days post-procedure])
研究者
研究点 (7)
Loading locations...
相似试验
招募中
不适用
PARTNER 3 Trial - Aortic Valve-in-ValveAortic Stenosis, SevereAortic StenosisNCT03003299Edwards Lifesciences125
进行中（未招募）
不适用
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationMitral DiseaseMitral RegurgitationNCT03230747Edwards Lifesciences72
已完成
不适用
SAPIEN 3 Ultra EU PMSAortic Valve StenosisAortic StenosisNCT04860752Edwards Lifesciences500
招募中
不适用
The ENCIRCLE TrialMitral Valve InsufficiencyMitral RegurgitationNCT04153292Edwards Lifesciences900
已完成
3 期
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)LymphomaNCT01889069Hoffmann-La Roche159