Radial Versus Femoral Secondary Access During TAVI

Aortic Stenosis Clinical Trial

— R-TAVI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03879824
• Other study ID #: 2611
• Status: Terminated
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: January 2021
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Disease
• Aortic Valve Stenosis
• Vascular Access Complication

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Carilion Clinic	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	Number of patients who underwent successful endovascular intervention to the valve implantation ileofemoral access site via the randomized secondary access point		Intra-procedural metric
Secondary	Radiation Dose (in minutes of fluoroscopy time)		Intra-procedural metric
Secondary	Radiation Dose (in milligrays, mGy)		Intra-procedural metric
Secondary	Procedure Start-Stop Time (minutes)		Intra-procedural metric
Secondary	Number of patients requiring conversion to secondary femoral access from secondary radial access		Intra-procedural metric
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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