Back to resultsRadial Versus Femoral Secondary Access During TAVI (R-TAVI)
Primary Purpose
Aortic Stenosis, Aortic Valve Disease, Vascular Access Complication
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Secondary Radial Artery Access
Secondary Femoral Artery Access
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis
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:
- 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
Sites / Locations
- Carilion Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radial Artery Secondary Access During TAVI
Femoral Artery Secondary Access During TAVI
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Number of patients who successfully undergo completion ileofemoral angiography of the valve implantation access site via the randomized secondary arterial access site
Number of patients who underwent successful endovascular intervention to the valve implantation ileofemoral access site via the randomized secondary access point
Radiation Dose (in minutes of fluoroscopy time)
Radiation Dose (in milligrays, mGy)
Procedure Start-Stop Time (minutes)
Number of patients requiring conversion to secondary femoral access from secondary radial access
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.
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
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03879824
Brief Title
Radial Versus Femoral Secondary Access During TAVI
Acronym
R-TAVI
Official Title
Radial Versus Femoral Secondary Access in Patients Undergoing Transcatheter Aortic Valve Implantation (R-TAVI): A Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
The PI and co-investigators would like to terminate the study given challenges with patient enrollment.
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Aortic Valve Disease, Vascular Access Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radial Artery Secondary Access During TAVI
Arm Type
Experimental
Arm Description
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
Arm Title
Femoral Artery Secondary Access During TAVI
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Secondary Radial Artery Access
Intervention Description
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
Intervention Name(s)
Secondary Femoral Artery Access
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding from the start of the TAVI procedure until hospital discharge
Description
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.
Time Frame
At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure)
Title
Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding within 30 days post TAVI procedure
Description
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.
Time Frame
Procedure start to 30-day follow-up.
Secondary Outcome Measure Information:
Title
Number of patients who successfully undergo completion ileofemoral angiography of the valve implantation access site via the randomized secondary arterial access site
Time Frame
Intra-procedural metric
Title
Number of patients who underwent successful endovascular intervention to the valve implantation ileofemoral access site via the randomized secondary access point
Time Frame
Intra-procedural metric
Title
Radiation Dose (in minutes of fluoroscopy time)
Time Frame
Intra-procedural metric
Title
Radiation Dose (in milligrays, mGy)
Time Frame
Intra-procedural metric
Title
Procedure Start-Stop Time (minutes)
Time Frame
Intra-procedural metric
Title
Number of patients requiring conversion to secondary femoral access from secondary radial access
Time Frame
Intra-procedural metric
Title
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
Description
The time of hospital discharge ranges from 24 -72 hours after TAVI procedure, depending on the patient's course of recovery.
Time Frame
At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure)
Title
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
Time Frame
At 30 Day Follow-Up
Title
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
Description
The time of hospital discharge ranges from 24 -72 hours after TAVI procedure, depending on the patient's course of recovery.
Time Frame
At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure)
Title
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
Time Frame
At 30 Day Follow-Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahul Sharma, MD
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Radial Versus Femoral Secondary Access During TAVI
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