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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
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.
Carilion Clinic
Roanoke, Virginia, United States
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.
Time frame: 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.
Time frame: Procedure start to 30-day follow-up.
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
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
Radiation Dose (in minutes of fluoroscopy time)
Time frame: Intra-procedural metric
Radiation Dose (in milligrays, mGy)
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Time frame: Intra-procedural metric
Procedure Start-Stop Time (minutes)
Time frame: Intra-procedural metric
Number of patients requiring conversion to secondary femoral access from secondary radial access
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: At 30 Day Follow-Up