Radial Versus Femoral Secondary Access During TAVI

NCT ID: NCT03879824

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2021-01-20

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.

Conditions

Aortic Stenosis; Aortic Valve Disease; Vascular Access Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radial Artery Secondary Access During TAVI

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

Group Type: EXPERIMENTAL

Secondary Radial Artery Access

Intervention Type: PROCEDURE

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.

Femoral Artery Secondary Access During TAVI

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

Group Type: ACTIVE_COMPARATOR

Secondary Femoral Artery Access

Intervention Type: PROCEDURE

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.

Interventions

Secondary Radial Artery Access

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.

Intervention Type: PROCEDURE

Secondary Femoral Artery Access

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carilion Clinic

OTHER

Sponsor Role: lead

Responsible Party

Rahul Sharma

Assistant Director Structural Heart & Valve Center/Assistant Professor of Medicine Virginia Tech Carilion School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rahul Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

Locations

Carilion Clinic

Roanoke, Virginia, United States

Countries

United States

Other Identifiers

2611

Identifier Type: -

Identifier Source: org_study_id