First in Human Surgical Implantation of Single Piece ADAPT® Treated 3D ALR (Aortic Leaflet Repair), Feasibility and Clinical Safety Study
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- rate of major paravalvular leak
研究概览
简要总结
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
详细描述
The purpose of this study is to conduct the initial clinical investigation of single piece ADAPT treated 3D - ALR (Aortic Leaflet Repair) to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical performance with significant improvements in clinical hemodynamic performance.
The ADAPT® technology is used to process animal derived tissues to produce implantable tissue prosthetic devices that are compatible with the human body. This technology has been shown to produce reliable, biocompatible and versatile regenerative prosthetic devices capable of being used instead of synthetic products currently used in many soft tissue repair applications.
15 patients with aortic valve insufficiency or stenosis will be enrolled in this single arm single site study.
Follow-up will continue through to 26 weeks.
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is older than 18 years of age and ≤ 85 years.
- •The subject's aortic annular measurements are ≥ 21 mm to < 27mm as confirmed on pre-op echo.
- •The subject is a candidate for Aortic Valve Replacement.
- •The subject has documented moderate or severe Aortic Stenosis and/or Aortic Insufficiency (defined as grade 2, 3 or 4).
- •The subject is willing and able to comply with specified follow-up requirements and evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve.
- •Patient has signed the informed consent
排除标准
- •All patients who require emergency surgery (within 24 hours of a presentation to an emergency department) for any reason.
- •Subject with a pre-existing valve prosthesis in the aortic position.
- •Patients requiring repair of other cardiac valves will be excluded.
- •Subject with active endocarditis.
- •Heavily calcified aortic roots or "porcelain aortas".
- •Leukopenia with a WBC (white Blood Cells) of less than
- •Acute anaemia with a haemoglobin less than 8 g/dL.
- •Platelet count less than 100,000 platelets/microliter, and if less than 150,000 platelets/microliter, platelet reduction of >10,000 platelets/microliter per day over two consecutive days (Note: Where a platelet count is less than 150,000 platelets/microliter but greater than 100,000 platelets/microliter, platelet count testing is to be conducted over 2 consecutive days. If platelets are reducing over those two consecutive days, the rate of reduction in platelets must be less than 10,000 platelets/microliter per day, otherwise the participant must be excluded).
- •History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions.
- •Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics).
- •Subjects in whom transesophageal echocardiography (TEE) is contraindicated.
- •Low EF < 50 %.
- •Life expectancy < 1 year, or severe comorbidities, such as cancer, dialysis, or severe COPD.
- •The subject is an illicit drug user, alcohol abuser, prisoner, institutionalised, or is unable to give informed consent.
- •The subject is pregnant or lactating (non-pregnancy to be confirmed by pregnancy test for all child bearing potential females).
- •Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
- •Myocardial Infarction (MI) within one month of trial inclusion.
- •Currently participating in, or have been recently exited from (within 30 days of enrollment in this study), or plan to be enrolled in another clinical
结局指标
主要结局
rate of major paravalvular leak
时间窗: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
derived Effective Orifice Area (EOA) range > 0.9 cm2 (19mm valve) to > 1.6 cm2 (27mm valve)
时间窗: 6 months following implantation
Hemodynamic Performance Assessment
rate of major hemorrhage
时间窗: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
rate of valve thrombosis
时间窗: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
rate of thromboembolism
时间窗: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
mean pressure gradient (mmHg) across the valve (less than 20 mmHg)
时间窗: 6 months following implantation
Hemodynamic Performance Assessment
rate of endocarditis
时间窗: 6 months following implantation
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
次要结局
- Rate of hemorrhage(6 months following implantation)
- Rate of Atrial Fibrillation 6 months post procedure(6 months post procedure)
- NYHA (New York Heart Association) class Improvement Assessment(6 months post procedure)
- number of days in hospital post procedure(30 days post procedure)
- hemoglobin assessment(6 months post procedure)
- Aspartate transaminase (AST)(6 months post procedure)
- Rate of all-caused death(6 months following implantation)
- Alanine transaminase (ALT)(6 months post procedure)
- Rate of valve-related reoperation(6 months following implantation)
- Rate of all-cause reoperation(6 months following implantation)
- Rate of valve related death(6 months following implantation)
- number of days in ICU(30 days post procedure)
- Rate of valve explant(6 months following implantation)
- Rate of Device deficiency(6 months following implantation)