Radial Versus Femoral Secondary Access in Patients Undergoing Transcatheter Aortic Valve Implantation (R-TAVI): A Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding from the start of the TAVI procedure until hospital discharge
研究概览
简要总结
The R-TAVI study is a randomized pilot study examining the use of the right radial artery versus the femoral artery for secondary vascular access during transcatheter aortic valve implantation (TAVI).
详细描述
The R-TAVI study is a prospective, single institution, pilot study in which eligible TAVI patients will be randomized pre-procedurally to receive either secondary radial artery (RA) access or femoral artery (FA) access during TAVI. Our study will take place over a projected 18 month enrollment period.
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
- 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
- •Patient meets eligibility for TAVR as decided upon by pre-TAVR testing (Echo, cardiac catheterization, CTA TAVR, 2 CT surgical consults, heart team discussion). 2) Undergoing TAVR procedure and follow-up at Carilion Clinic Cardiology Roanoke Memorial Hospital (CRMH) 3) Patient's secondary vascular access can be performed femorally OR radially, as determined by TAVR operator after review of pre-TAVR CT scan imaging.
- •Interventional Cardiologist performing the TAVR agrees to consider patient for enrollment.
- •Patient provides consent 6) Age ≥ 18 years old 7) No evidence of precluding arterial disease of both femoral arteries 8) No evidence of precluding arterial disease of right radial and subclavian arteries 9) Must have palpable pulses in both radial arteries
排除标准
- •Review of pre-TAVR CT scan imaging deems patient unsuitable for radial OR femoral secondary access based on presence of excessive calcification, stenosis, or tortuosity of the femoral, subclavian, or innominate arteries.
- •Valve implantation (primary access) planned via alternative vascular access (trans-caval, axillary, carotid, direct aortic, trans-apical)-as determined by implanting Interventional Cardiologist/TAVR operator.
- •Prior coronary artery bypass graft surgery in which a radial artery graft was harvested and used as a conduit.
- •Patients on hemodialysis OR with arteriovenous fistulas.
- •Interventional Cardiologist performing the TAVR declines patient consideration in the study.
- •Patient declines consent.
- •Urgent or emergent TAVI cases
- •Patient is already participating in another clinical research study
结局指标
主要结局
Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding from the start of the TAVI procedure until hospital discharge
时间窗: At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure)
We will report the number of patients who develop death, myocardial infarction, stroke, and/or ACUITY major bleeding definitions from the start of the TAVI procedure to the the time of patient's hospital discharge after undergoing the TAVI procedure. The time of hospital discharge ranges from 24 -72 hours after TAVI procedure, depending on the patient's course of recovery. This will be reported as a composite incidence of death, MI, stroke and ACUITY major bleeding.
Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding within 30 days post TAVI procedure
时间窗: Procedure start to 30-day follow-up.
We will report the number of patients who develop death, myocardial infarction, stroke, and/or ACUITY major bleeding definitions from the start of the TAVI procedure to the the time of their 30-day post TAVI follow up This will be reported as a 30-day composite incidence of death, MI, stroke and ACUITY major bleeding.
次要结局
- Number of patients who developed a major vascular complications, as defined by the 2nd Valve Academic Research Consortium (VARC-2) Criteria from the start of the TAVI procedure until hospital discharge(At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure))
- Number of patients who successfully undergo completion ileofemoral angiography of the valve implantation access site via the randomized secondary arterial access site(Intra-procedural metric)
- Number of patients who underwent successful endovascular intervention to the valve implantation ileofemoral access site via the randomized secondary access point(Intra-procedural metric)
- Procedure Start-Stop Time (minutes)(Intra-procedural metric)
- Number of patients requiring conversion to secondary femoral access from secondary radial access(Intra-procedural metric)
- Number of patients who developed a minor vascular complications, as defined by the 2nd Valve Academic Research Consortium (VARC-2) Criteria from the start of the TAVI procedure until hospital discharge(At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure))
- Radiation Dose (in minutes of fluoroscopy time)(Intra-procedural metric)
- Radiation Dose (in milligrays, mGy)(Intra-procedural metric)
- Number of patients who developed a major vascular complications, as defined by the 2nd Valve Academic Research Consortium (VARC-2) Criteria within 30 days post TAVI procedure(At 30 Day Follow-Up)
- Number of patients who developed a minor vascular complications, as defined by the 2nd Valve Academic Research Consortium (VARC-2) Criteria within 30 days post TAVI procedure(At 30 Day Follow-Up)
研究者
Rahul Sharma
Assistant Director Structural Heart & Valve Center/Assistant Professor of Medicine Virginia Tech Carilion School of Medicine
Carilion Clinic