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The PI and co-investigators would like to terminate the study given challenges with patient enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Rahul Sharma, MD | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| 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. |
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| 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 |