Radial Versus Femoral Secondary Access During TAVI

Stopped early · Not applicable

Conditions studied: Aortic Stenosis, Aortic Valve Disease, Vascular Access Complication

In brief

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).

Key facts

Study ID

NCT03879824

Run by

Carilion Clinic

People needed

15

Starts

2019-05-30

Expected to finish

2021-01-20

Last updated by the study team

2021-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Carilion Clinic — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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