GUARDIAN Australian Feasibility Study: Safety and Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary Endpoint
研究概览
简要总结
The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device. The study will be conducted to evaluate the device design concept with respect to clinical safety and device functionality.
详细描述
This is a prospective, single-arm, multi-center, open study to assess the clinical performance and safety of the Point-Guard CEPD during a TAVR procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •The patient is ≥18 years of age;
- •The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
- •The patient is willing to comply with protocol-specified follow-up evaluations;
- •The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board or Ethics Committee.
排除标准
- •TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- •Anatomy that precludes safe delivery and retrieval of the investigational device.
- •Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
- •Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
- •Patients with uncontrolled bleeding disorders.
- •Patients who are pregnant, as confirmed by a positive pregnancy test.
- •General Exclusion Criteria
- •TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- •Anatomy that precludes safe delivery and retrieval of the investigational device.
- •Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
- •Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
- •Patients with uncontrolled bleeding disorders.
- •Patients who are pregnant, as confirmed by a positive pregnancy test.
- •Magnetic resonance imaging exclusion criteria:
- •Body Mass Index (BMI) and/or total body weight precluding imaging in scanner.
- •Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
- •High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., subjects with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
- •Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
- •Claustrophobia precluding MRI scanning.
结局指标
主要结局
Primary Endpoint
时间窗: From beginning of TAVI procedure to end.
Technical success, defined as successful deployment, positioning and retrieval per the Instructions For Use (IFU), with minimal device interference, and as outlined below: * Deployment of the Point-Guard filter unit from the Delivery sheath into the aortic arch; * Positioning of the Point-Guard device within the aortic arch; * Retrieving and removing the Point-Guard device intact; * Minimal device interference (operator assessed).
Primary Safety Endpoints
时间窗: Beginning of TAVI procedure to 30 days post-procedure.
1. Primary Safety Endpoint: TAVR procedure complications associated with the delivery, positioning, and removal of the test device. 2. Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3) within 72 hours or discharge, whatever occurs first and at 30 days.
次要结局
未报告次要终点