NCT01802788已完成不适用
International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,032
- 试验地点
- 60
- 主要终点
- Percentage of Participants With All-cause Mortality
研究概览
简要总结
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
详细描述
This is an international multicenter, prospective, non-randomized clinical investigation without concurrent or matched control, designed to assess the mid-term safety and performance of the Portico valve in patients with severe symptomatic aortic stenosis whom are high risk for surgical valve replacement. The primary endpoint is 1 year all-cause mortality. In addition, the performance and safety profile of the Portico valve will be further evaluated at 30 days, 1 year, and annually through 5 years post-implant.
The investigation will be conducted at approximately 65 centers in approximately 15 countries in Europe, Middle-East, Africa, Canada, Australia and New Zealand.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.
- •Patient has been referred for a Portico Valve implant as per Heart Team decision or patient has received a Portico Valve as per participation in an SJM sponsored regulatory or first-in-human trial.
- •Patient has senile degenerative aortic valve stenosis confirmed by echocardiographically derived criteria*:
- •An initial aortic valve area (AVA) of less than or equal to (≤) 1.0 cm2 (or indexed EOA less than or equal to (≤) 0.6 cm2/m2) AND
- •A mean gradient greater than (>)40 mmHg or jet velocity greater than (>)4.0 m/s or Doppler Velocity Index less than (<)0.
- •If the mean gradient is <40 mmHg and left ventricular ejection fraction (LVEF) <55%, then the site may as well perform a dobutamine stress echo to see if the mean gradient increases to >40 mmHg." (Baseline measurement taken by echo within 6 months of index procedure.)
- •Patient has a life expectancy more than (>) 12 months.
- •For patients enrolled in a French site:
- •Patient is at high risk for surgery as demonstrated by a Logistic EuroSCORE equal or more than (≥) 20 and/or a Society of Thoracic Surgeon (STS) mortality risk score of more than (>) 10% and/or by clinical judgment of the Heart Team based on the individual risk profile (comorbidities).
- •Not applicable for a patient who has received a Portico Valve as per participation in an SJM sponsored Regulatory or First-In-Human trial.
排除标准
- •Any case in which the Portico Valve would not be indicated for the patient as per current instructions for use (i.e any "off-label" use).
- •Patient has any other aortic valve than tricuspid one.
- •Patient has a prosthetic valve or ring in the aortic position.
- •Patient needs a concomitant structural heart procedure..
- •Patient needs the usage of an embolic protection device.
- •Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.
- •Patient is pregnant
结局指标
主要结局
Percentage of Participants With All-cause Mortality
时间窗: 1 year post implant
Percentage of participants that died for any reason at 1 year post implantation
次要结局
- Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A(30 days post implant)
- Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)(30 days through 5 years post implant)
- Mean Quality of Life Assessment in Cohort A(30 days and 1 year post implant)
- Percentage of Participants With All Cause Mortality in Cohort A(30 days through 5 years post implant)
- Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B(30 days through 5 years post implant)
- Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A(30 days through 5 years post implant)
- Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A(30 days through 5 years post implant)
- Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A(30 days post implant)
- Mean Six Minute Walk Test (6MWT)(30 days through 5 years post implant)
- Number of Participants With Transient Ischemic Attack in Cohort B(30 days through 5 years post implantation)
- Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B(30 days through 5 years post implant)
- Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A(30 days through 5 years post implant)
- Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B(30 days through 5 years post implant)
- Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B(30 days through 5 years post implant)
- Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)(30 days through 5 years post implant)
- Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A(30 days post implant)
- Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure(5 years post implant)
- Percentage of Participants With Transient Ischemic Attack in Cohort A(30 days through 5 years post implantation)
- Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A(5 years post implant)
- Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B(5 years post implant)
- Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A(5 years post implant)
- Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B(5 years post implant)
- Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A(1 year post implant)
- Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)(5 years post implant)
研究者
研究点 (60)
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