Minimally-Invasive Upper Extremity Approach Versus Lower Extremity Approach for Transcatheter Aortic Valve Implantation (TAVI) Accessory Access Sites; A Prospective, Multicenter, Investigator-Initiated, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 9
- 主要终点
- Clinically relevant bleeding of the randomized access site; either diagnostic or pacemaker access site, or both
研究概览
简要总结
The goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach for accessory access sites in patients undergoing a transcatheter aortic valve implantation.
The main questions it aims to answer are whether a 'minimally invasive, upper extremity' approach as compared with the standard 'lower extremity' approach:
- Is associated with less clinically relevant access site-related bleeding complications.
- Is associated with a shorter time to mobilization after TAVI.
- Is associated with a shorter duration of hospitalization.
- Has the same early safety outcomes at 30 days post-TAVI.
Participants will be subject to the usual care surrounding a TAVI procedure but will also will be asked to fill out two questionnaires before and after TAVI:
- Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)
- Lower Extremity Functional Scale (LEFS)
Researchers will compare the minimally invasive, upper extremity group with the standard lower extremity to see if there are difference regarding the posed questions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor, being the trial statistician, is blinded for the treatment groups.
Groups are defined as group A and B during the preparation of the statistical tests. Only after performing the required statistical tests the data will be unblinded.
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
- •Patients must be > 18 years old.
- •Written informed consent is obtained from all patients.
- •Planned for transfemoral TAVI procedure.
排除标准
- •Inability to obtain informed consent.
- •Contra-indication for brachial or femoral vein access (temporary pacemaker access site).
- •Contra-indication for radial or femoral artery access (diagnostic access site).
- •Use of a cerebral embolic protection device (CEPD) if this requires an additional (arterial) access site.
结局指标
主要结局
Clinically relevant bleeding of the randomized access site; either diagnostic or pacemaker access site, or both
时间窗: "Through 30 days"
Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding; In case a clinically relevant bleeding occurs in both the randomized diagnostic access site and the randomized pacemaker access site, these will be combined and the highest classification of the two BARC bleedings will be scored. BARC classification: a classification scoring bleeding complication based on the clinical actions that follow in which type 1 bleeding is not actionable and type 5 bleeding is fatal.
次要结局
- Moderate or severe aortic regurgitation("30 days")
- Clinically relevant bleeding not related to the randomized access sites("Through 30 days")
- Valve Academic Research Consortium-3 (VARC) type 2-4 bleeding("30 days")
- Total duration of hospitalization("during index hospitalization, approximately 3 days")
- Composite endpoint of all clinically relevant bleeding of the access sites; either diagnostic or pacemaker access site or primary (TAVI) access site("Through 30 days")
- All-cause mortality("30 days")
- All stroke("30 days")
- Acute kidney injury stage 3 or 4("30 days")
- Surgery or intervention related to the device("30 days")
- Time to mobilization("during index hospitalization, approximately 3 days - often hours after TAVI procedure")
- Major vascular, access-related, or cardiac structural complications("30 days")
- New permanent pacemaker due to procedure-related conduction abnormalities("30 days")