Radial Versus Femoral Secondary Access During TAVI

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Radial Versus Femoral Secondary Access in Patients Undergoing Transcatheter Aortic Valve Implantation (R-TAVI): A Randomized Pilot Study

Conditions
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Aortic Stenosis, Aortic Valve Disease, Vascular Access Complication

Intervention / Treatment
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* Procedure: Secondary Radial Artery Access
* Procedure: Secondary Femoral Artery Access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) 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. 4) Interventional Cardiologist performing the TAVR agrees to consider patient for enrollment. 5) 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radial Artery Secondary Access During TAVI<br>Patients randomized to this arm will undergo primary access for valve placement through the femoral artery and will have secondary vascular access for placement of the pigtail catheter through the radial artery (right radial artery only) during their transcatheter aortic valve implantation (TAVI) The active intervention in this arm of the study is secondary radial artery access during TAVI | Procedure: Secondary Radial Artery Access<br>* Patients undergoing transcatheter aortic valve implantation (TAVI) will receive secondary arterial access via percutaneous access of the right radial artery for the purpose of insertion of a standard pigtail catheter for aortic route angiography during TAVI.<br>|
| Active Comparator: Femoral Artery Secondary Access During TAVI<br>Patients randomized to this arm will undergo primary access for valve placement through the femoral artery and will have secondary vascular access for placement of the pigtail catheter through the contralateral femoral artery artery during their transcatheter aortic valve implantation (TAVI) The active intervention in this arm of the study is secondary femoral artery access during TAVI | Procedure: Secondary Femoral Artery Access<br>* Patients undergoing transcatheter aortic valve implantation (TAVI) will receive secondary arterial access via percutaneous access of the contralateral femoral artery for the purpose of insertion of a standard pigtail catheter for aortic route angiography during TAVI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding from the start of the TAVI procedure until hospital discharge | 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. | At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure) | 
| Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding within 30 days post TAVI 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 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. | Procedure start to 30-day follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Radiation Dose (in minutes of fluoroscopy time) |  | Intra-procedural metric | 
| Radiation Dose (in milligrays, mGy) |  | 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 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 | The time of hospital discharge ranges from 24 -72 hours after TAVI procedure, depending on the patient's course of recovery. | At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure) | 
| 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 from the start of the TAVI procedure until hospital discharge | The time of hospital discharge ranges from 24 -72 hours after TAVI procedure, depending on the patient's course of recovery. | At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure) | 
| 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 |