Radial Versus Femoral Secondary Access During TAVI

Not Applicable

Terminated

• Conditions: Vascular Access Complication; Aortic Stenosis; Aortic Valve Disease
• Interventions: Procedure: Secondary Radial Artery Access; Procedure: Secondary Femoral Artery Access

• Registration Number: NCT03879824
• Lead Sponsor: Carilion Clinic

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 Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-19
• Study Start: 2019-05-30
• Status Verified: 2021-01
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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.

2. Interventional Cardiologist performing the TAVR agrees to consider patient for enrollment.

3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radial Artery Secondary Access During TAVI	Secondary Radial Artery Access	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
Femoral Artery Secondary Access During TAVI	Secondary Femoral Artery Access	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

Primary Outcome Measures

Name	Time	Method
Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding 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)	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	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.

Secondary Outcome Measures

Name	Time	Method
Radiation Dose (in minutes of fluoroscopy time)	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	At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure)	The time of hospital discharge ranges from 24 -72 hours after TAVI procedure, depending on the patient's course of recovery.
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 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)	The time of hospital discharge ranges from 24 -72 hours after TAVI procedure, depending on the patient's course of recovery.
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

Trial Locations

Locations (1)

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States