Aortic StenosisR-TAVINCT03879824
Radial Versus Femoral Secondary Access During TAVI
A study testing Secondary Radial Artery Access and Secondary Femoral Artery Access in people with Aortic Stenosis and Aortic Valve Disease, run by Carilion Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Aortic Valve Disease, Vascular Access Complication
- What is being tested?
- Secondary Radial Artery Access and Secondary Femoral Artery Access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radial Versus Femoral Secondary Access in Patients Undergoing Transcatheter Aortic Valve Implantation (R-TAVI): A Randomized Pilot Study
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).
Read the 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.
- Being tested
- Secondary Radial Artery Access, Secondary Femoral Artery Access
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary Radial Artery AccessProcedure or surgery
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 AccessProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Secondary Radial Artery Access |
| 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 Receives: Procedure: Secondary Femoral Artery Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Procedure start to 30-day follow-up.
Secondary outcomes (10)
Number of patients who successfully undergo completion ileofemoral angiography of the valve implantation access site via the randomized secondary arterial access site
Measured: Intra-procedural metric
Number of patients who underwent successful endovascular intervention to the valve implantation ileofemoral access site via the randomized secondary access point
Measured: Intra-procedural metric
Radiation Dose (in minutes of fluoroscopy time)
Measured: Intra-procedural metric
Radiation Dose (in milligrays, mGy)
Measured: Intra-procedural metric
Procedure Start-Stop Time (minutes)
Measured: Intra-procedural metric
Number of patients requiring conversion to secondary femoral access from secondary radial access
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: At 30 Day Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start30 May 2019
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Why it stopped: The PI and co-investigators would like to terminate the study given challenges with patient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahul Sharma, Carilion Clinic
- Investigators
- Rahul Sharma, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879824
- Sponsor's protocol ID
- 2611
- Acronym
- R-TAVI
- Status last verified
- Jan 2021
- First submitted
- 11 Dec 2018
- Last updated
- 25 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Versus Femoral Secondary Access in Patients Undergoing Transcatheter Aortic Valve Implantation (R-TAVI): A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03879824
- Acronym / sponsor ID
- R-TAVI / 2611
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI and co-investigators would like to terminate the study given challenges with patient enrollment.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial Artery Secondary Access During TAVI | Experimental | Procedure: Secondary Radial Artery AccessPatients 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 |
| Femoral Artery Secondary Access During TAVI | Active comparator | Procedure: Secondary Femoral Artery AccessPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secondary Radial Artery AccessPatients 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. | Procedure or surgery | Radial Artery Secondary Access During TAVI |
| Secondary Femoral Artery AccessPatients 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. | Procedure or surgery | Femoral Artery Secondary Access During TAVI |
Primary outcome
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.
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.
10 secondary outcomes
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)
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
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
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
Results and safety
The study was stopped early (reason given: The PI and co-investigators would like to terminate the study given challenges with patient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Aortic Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Sharma, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secondary Radial Artery Access and Secondary Femoral Artery Access in people with Aortic Stenosis and Aortic Valve Disease, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The PI and co-investigators would like to terminate the study given challenges with patient enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.