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Radial Versus Femoral Secondary Access During TAVI (R-TAVI)

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ClinicalTrials.gov Identifier: NCT03879824
Recruitment Status : Terminated (The PI and co-investigators would like to terminate the study given challenges with patient enrollment.)
First Posted : March 19, 2019
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Rahul Sharma, Carilion Clinic

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).

Condition or disease Intervention/treatment Phase
Aortic Stenosis Aortic Valve Disease Vascular Access Complication Procedure: Secondary Radial Artery Access Procedure: Secondary Femoral Artery Access Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radial Versus Femoral Secondary Access in Patients Undergoing Transcatheter Aortic Valve Implantation (R-TAVI): A Randomized Pilot Study
Actual Study Start Date : May 30, 2019
Actual Primary Completion Date : January 20, 2021
Actual Study Completion Date : January 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radial Artery Secondary 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 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
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.

Active Comparator: Femoral Artery Secondary 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

Procedure: 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.




Primary Outcome Measures :
  1. Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding from the start of the TAVI procedure until hospital discharge [ Time Frame: At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post 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 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.


  2. Number of Patients who Develop Death, MI, Stroke, and ACUITY major bleeding within 30 days post TAVI procedure [ Time Frame: Procedure start to 30-day follow-up. ]

    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 :
  1. 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 ]
  2. 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 ]
  3. Radiation Dose (in minutes of fluoroscopy time) [ Time Frame: Intra-procedural metric ]
  4. Radiation Dose (in milligrays, mGy) [ Time Frame: Intra-procedural metric ]
  5. Procedure Start-Stop Time (minutes) [ Time Frame: Intra-procedural metric ]
  6. Number of patients requiring conversion to secondary femoral access from secondary radial access [ Time Frame: Intra-procedural metric ]
  7. 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 [ Time Frame: At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure) ]
    The time of hospital discharge ranges from 24 -72 hours after TAVI procedure, depending on the patient's course of recovery.

  8. 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 ]
  9. 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 [ Time Frame: At time of hospital discharge (ranges from 24 hours post procedure - 72 hours post procedure) ]
    The time of hospital discharge ranges from 24 -72 hours after TAVI procedure, depending on the patient's course of recovery.

  10. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879824


Locations
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United States, Virginia
Carilion Clinic
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Carilion Clinic
Investigators
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Principal Investigator: Rahul Sharma, MD Carilion Clinic
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Responsible Party: Rahul Sharma, Assistant Director Structural Heart & Valve Center/Assistant Professor of Medicine Virginia Tech Carilion School of Medicine, Carilion Clinic
ClinicalTrials.gov Identifier: NCT03879824    
Other Study ID Numbers: 2611
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction