Brief Title
Radial Versus Femoral Secondary Access During TAVI
Official Title
Radial Versus Femoral Secondary Access in Patients Undergoing Transcatheter Aortic Valve Implantation (R-TAVI): A Randomized Pilot Study
Brief Summary
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
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.
Study Type
Interventional
Primary Outcome
Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding from the start of the TAVI procedure until hospital discharge
Secondary Outcome
Number of patients who successfully undergo completion ileofemoral angiography of the valve implantation access site via the randomized secondary arterial access site
Condition
Aortic Stenosis
Intervention
Secondary Radial Artery Access
Study Arms / Comparison Groups
Radial Artery Secondary Access During TAVI
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
80
Start Date
May 30, 2019
Completion Date
August 30, 2021
Primary Completion Date
June 30, 2021
Eligibility Criteria
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:
1. 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.
2. 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.
3. Prior coronary artery bypass graft surgery in which a radial artery graft was
harvested and used as a conduit.
4. Patients on hemodialysis OR with arteriovenous fistulas.
5. Interventional Cardiologist performing the TAVR declines patient consideration in the
study.
6. Patient declines consent.
7. Urgent or emergent TAVI cases
8. Patient is already participating in another clinical research study
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Rahul Sharma, MD, 540-266-6397, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03879824
Organization ID
2611
Responsible Party
Principal Investigator
Study Sponsor
Carilion Clinic
Study Sponsor
Rahul Sharma, MD, Principal Investigator, Carilion Clinic
Verification Date
May 2020