Radial Versus Femoral Secondary Access During TAVI

NCT03879824 | Terminated

• 1 other identifier: 2611
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Stenosis; Aortic Valve Disease; Vascular Access Complication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (2)

Radial Artery Secondary Access During TAVI

EXPERIMENTAL

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

Femoral Artery Secondary Access During TAVI

ACTIVE COMPARATOR

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

Interventions

Secondary Radial Artery Access 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.

Radial Artery Secondary Access During TAVI

Secondary Femoral Artery Access 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.

Femoral Artery Secondary Access During TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Rahul Sharma, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director Structural Heart & Valve Center/Assistant Professor of Medicine Virginia Tech Carilion School of Medicine

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: March 19, 2019
• Study Start: May 30, 2019
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)