Radial Versus Femoral Secondary Access During TAVI (R-TAVI)

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

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).

Study Overview

• Status: Terminated
• Conditions: Aortic Stenosis; Aortic Valve Disease; Vascular Access Complication
• Intervention / Treatment: Procedure: Secondary Radial Artery Access; Procedure: Secondary Femoral Artery Access

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
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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.
Active Comparator: 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	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: Rahul Sharma, MD, Carilion Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Disease
• Other Study ID Numbers: 2611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No