Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation

An observational study of Aortic Valve Stenosis, run by Ignacio J. Amat Santos at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Stenosis
What is being tested?: Transcatheter aortic valve implantation
Type of treatment: Medical device
How many people: 75 participants
Where: 1 siteSpain
Study dates: 1 Jul 2019to 30 Jun 2020
Phase: Observational
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

Study population: Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019. All-comers

Who may be able to join

Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019.

Who cannot join

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clínico Universitario de Valladolid
Valladolid, 47003

Other trials in Spain

About this study

Official title: Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation: The TRANSAX Study

Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.

Read the detailed description

Aortic stenosis (AS) is the most frequently treated heart valve disease in our society. Transcatheter aortic valve implantation (TAVI) was originally described through an antegrade transeptal route by Cribier and colleagues in 2002. Because of the complexity of the procedure and risks of damaging the mitral apparatus, this approach was abandoned in favor of less challenging alternatives, with transfemoral (TF) route as primary option. Nevertheless, the TF approach is not feasible or of high risk in between 15 and 35% of the patients and vascular complications have been shown to be an independent predictor of death warranting alternative access techniques for TAVI. In this regard, the transapical, direct aortic, transcarotid, transcaval, and transubclavian/transaxillary (TSc) implantation routes currently serve as alternative access options. The TSc approach was initially used in selected cases. However, recent series suggest that TSc may provide better outcomes than alternative routes when TF is inadequate. Additionally, same studies suggest that, as compared to TF approach, TSc TAVI may present lower rate of vascular complications with comparable rates of other major outcomes despite the worse baseline profile of patients who are considered inappropriate for TF procedures. Moreover, fully-percutaneous TSc approach can be successfully performed with low rate of complications as was recently proposed by some authors. However, comparisons have been based in small series of cases, most of them with former iteration of TAVI devices, and a formal prospective comparison has never been performed. Therefore, our aim is to gather all cases of fully-percutaneous TSc and TF approaches for TAVI in Spain and Portugal and compare the standardized safety and efficacy endpoints through a matched analysis.

Conditions: Aortic Valve Stenosis
Being tested: Transcatheter aortic valve implantation
Keywords: Transcatheter aortic valve Implantation (TAVI), Transaxillary approach
Medical subject headings: Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcatheter aortic valve implantationDevice
Transcatheter aortic valve implantation

Study groups in NCT04274751
Study group	Role	What they receive
Transaxillary		TAVI, transaxillary approach Receives: Device: Transcatheter aortic valve implantation
Transfemoral		TAVI, transfemoral approach Receives: Device: Transcatheter aortic valve implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

30-day death, stroke or embolic events, PVE or sepsis
Combined endpoint of death, stroke or embolic events, PVE or sepsis at 30-day follow up.
Measured: 30 day
1-year death, stroke or embolic events, PVE or sepsis
Combined endpoint of death, stroke or embolic events, PVE or sepsis at 1-year follow up.
Measured: 1 year
Intraprocedural Vascular complications
Intraprocedural Vascular complications
Measured: Intraprocedural
In-hospital Vascular complications
In-hospital Vascular complications
Measured: 7-days

Secondary outcomes (2)

Short term complications related to the approach.
Short term complications related to the approach.
Measured: 30-days
Mid term complications related to the approach.
Mid term complications related to the approach.
Measured: 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201930 Jun 2020

First posted18 Feb 2020
Study start1 Jul 2019
Primary completion30 Jun 2020
Study completion30 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Aortic Valve 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04274751
Sponsor's protocol ID: CASVE PI-19-1428
Acronym: TRANSAX
Status last verified: Oct 2021
First submitted: 14 Jan 2020
Last updated: 26 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Brennan JM, Holmes DR, Sherwood MW, Edwards FH, Carroll JD, Grover FL, Tuzcu EM, Thourani V, Brindis RG, Shahian DM, Svensson LG, O'Brien SM, Shewan CM, Hewitt K, Gammie JS, Rumsfeld JS, Peterson ED, Mack MJ. The association of transcatheter aortic valve replacement availability and hospital aortic valve replacement volume and mortality in the United States. Ann Thorac Surg. 2014 Dec;98(6):2016-22; discussion 2022. doi: 10.1016/j.athoracsur.2014.07.051. Epub 2014 Oct 29.
PubMed 25443009
Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.
PubMed 12473543
Kurra V, Schoenhagen P, Roselli EE, Kapadia SR, Tuzcu EM, Greenberg R, Akhtar M, Desai MY, Flamm SD, Halliburton SS, Svensson LG, Sola S. Prevalence of significant peripheral artery disease in patients evaluated for percutaneous aortic valve insertion: Preprocedural assessment with multidetector computed tomography. J Thorac Cardiovasc Surg. 2009 May;137(5):1258-64. doi: 10.1016/j.jtcvs.2008.12.013.
PubMed 19380001
Caceres M, Braud R, Roselli EE. The axillary/subclavian artery access route for transcatheter aortic valve replacement: a systematic review of the literature. Ann Thorac Surg. 2012 Mar;93(3):1013-8. doi: 10.1016/j.athoracsur.2011.10.056. Epub 2012 Jan 5.
PubMed 22226233
Walther T, Simon P, Dewey T, Wimmer-Greinecker G, Falk V, Kasimir MT, Doss M, Borger MA, Schuler G, Glogar D, Fehske W, Wolner E, Mohr FW, Mack M. Transapical minimally invasive aortic valve implantation: multicenter experience. Circulation. 2007 Sep 11;116(11 Suppl):I240-5. doi: 10.1161/CIRCULATIONAHA.106.677237.
PubMed 17846311
Bapat V, Khawaja MZ, Attia R, Narayana A, Wilson K, Macgillivray K, Young C, Hancock J, Redwood S, Thomas M. Transaortic Transcatheter Aortic valve implantation using Edwards Sapien valve: a novel approach. Catheter Cardiovasc Interv. 2012 Apr 1;79(5):733-40. doi: 10.1002/ccd.23276. Epub 2011 Sep 26.
PubMed 21805602
Modine T, Sudre A, Delhaye C, Fayad G, Lemesle G, Collet F, Koussa M. Transcutaneous aortic valve implantation using the left carotid access: feasibility and early clinical outcomes. Ann Thorac Surg. 2012 May;93(5):1489-94. doi: 10.1016/j.athoracsur.2012.01.030. Epub 2012 Mar 28.
PubMed 22464036
Greenbaum AB, O'Neill WW, Paone G, Guerrero ME, Wyman JF, Cooper RL, Lederman RJ. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2795-804. doi: 10.1016/j.jacc.2014.04.015. Epub 2014 May 7.
PubMed 24814495
Schofer N, Deuschl F, Conradi L, Lubos E, Schirmer J, Reichenspurner H, Blankenberg S, Treede H, Schafer U. Preferential short cut or alternative route: the transaxillary access for transcatheter aortic valve implantation. J Thorac Dis. 2015 Sep;7(9):1543-7. doi: 10.3978/j.issn.2072-1439.2015.07.27.
PubMed 26543600
Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011 Nov 8;58(20):2130-8. doi: 10.1016/j.jacc.2011.08.050. Epub 2011 Oct 20.
PubMed 22019110
Amat-Santos IJ, Rojas P, Gutierrez H, Vera S, Castrodeza J, Tobar J, Goncalves-Ramirez LR, Carrasco M, Catala P, San Roman JA. Transubclavian approach: A competitive access for transcatheter aortic valve implantation as compared to transfemoral. Catheter Cardiovasc Interv. 2018 Nov 1;92(5):935-944. doi: 10.1002/ccd.27485. Epub 2018 Jan 3.
PubMed 29314570
Garcia DC, Benjo A, Cardoso RN, Macedo FY, Chavez P, Aziz EF, Herzog E, Alam M, de Marchena E. Device stratified comparison among transfemoral, transapical and transubclavian access for Transcatheter Aortic Valve Replacement (TAVR): a meta-analysis. Int J Cardiol. 2014 Mar 15;172(2):e318-21. doi: 10.1016/j.ijcard.2013.12.162. Epub 2014 Jan 9. No abstract available.
PubMed 24485611
Schafer U, Deuschl F, Schofer N, Frerker C, Schmidt T, Kuck KH, Kreidel F, Schirmer J, Mizote I, Reichenspurner H, Blankenberg S, Treede H, Conradi L. Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients. Int J Cardiol. 2017 Apr 1;232:247-254. doi: 10.1016/j.ijcard.2017.01.010. Epub 2017 Jan 7.
PubMed 28118931
Amat-Santos IJ, Santos-Martinez S, Conradi L, Taramasso M, Poli A, Romaguera R, Pan M, Bagur R, Del Valle R, Nombela-Franco L, Bhadra OD, Aparisi A, Redondo A, Gutierrez H, Gomez I, Roman JAS. Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E291-E298. doi: 10.1002/ccd.29423. Epub 2020 Dec 14.
PubMed 33315296

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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Acute Pain
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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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
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All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation: The TRANSAX Study
ClinicalTrials.gov ID: NCT04274751
Acronym / sponsor ID: TRANSAX / CASVE PI-19-1428
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter aortic valve Implantation (TAVI), Transaxillary approach
Study type: Observational
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Ignacio J. Amat SantosUniversity, hospital or other
Collaborators: Boston Scientific Corporation
Study start: 1 Jul 2019 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 30 Jun 2020 (actual)
First posted: 18 Feb 2020 (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.

Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Transaxillary	–	Device: Transcatheter aortic valve implantationTAVI, transaxillary approach
Transfemoral	–	Device: Transcatheter aortic valve implantationTAVI, transfemoral approach

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019. All-comers

Key inclusion criteria (1 listed)

Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019.

Key exclusion criteria (1 listed)

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
Transcatheter aortic valve implantationTranscatheter aortic valve implantation	Device	Transaxillary, Transfemoral

Primary outcome

30-day death, stroke or embolic events, PVE or sepsis
Time frame: 30 day
Combined endpoint of death, stroke or embolic events, PVE or sepsis at 30-day follow up.
1-year death, stroke or embolic events, PVE or sepsis
Time frame: 1 year
Combined endpoint of death, stroke or embolic events, PVE or sepsis at 1-year follow up.
Intraprocedural Vascular complications
Time frame: Intraprocedural
Intraprocedural Vascular complications
In-hospital Vascular complications
Time frame: 7-days
In-hospital Vascular complications

2 secondary outcomes

Short term complications related to the approach.
Time frame: 30-days
Mid term complications related to the approach.
Time frame: 1-year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
Background: PubMed 25443009Brennan JM, Holmes DR, Sherwood MW, Edwards FH, Carroll JD, Grover FL, Tuzcu EM, Thourani V, Brindis RG, Shahian DM, Svensson LG, O'Brien SM, Shewan CM, Hewitt K, Gammie JS, Rumsfeld JS, Peterson ED, Mack MJ. The association of transcatheter aortic valve replacement availability and hospital aortic valve replacement volume and mortality in the United States. Ann Thorac Surg. 2014 Dec;98(6):2016-22; discussion 2022. doi: 10.1016/j.athoracsur.2014.07.051. Epub 2014 Oct 29.
Background: PubMed 12473543Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.
Background: PubMed 19380001Kurra V, Schoenhagen P, Roselli EE, Kapadia SR, Tuzcu EM, Greenberg R, Akhtar M, Desai MY, Flamm SD, Halliburton SS, Svensson LG, Sola S. Prevalence of significant peripheral artery disease in patients evaluated for percutaneous aortic valve insertion: Preprocedural assessment with multidetector computed tomography. J Thorac Cardiovasc Surg. 2009 May;137(5):1258-64. doi: 10.1016/j.jtcvs.2008.12.013.
Background: PubMed 22226233Caceres M, Braud R, Roselli EE. The axillary/subclavian artery access route for transcatheter aortic valve replacement: a systematic review of the literature. Ann Thorac Surg. 2012 Mar;93(3):1013-8. doi: 10.1016/j.athoracsur.2011.10.056. Epub 2012 Jan 5.
Background: PubMed 17846311Walther T, Simon P, Dewey T, Wimmer-Greinecker G, Falk V, Kasimir MT, Doss M, Borger MA, Schuler G, Glogar D, Fehske W, Wolner E, Mohr FW, Mack M. Transapical minimally invasive aortic valve implantation: multicenter experience. Circulation. 2007 Sep 11;116(11 Suppl):I240-5. doi: 10.1161/CIRCULATIONAHA.106.677237.
Background: PubMed 21805602Bapat V, Khawaja MZ, Attia R, Narayana A, Wilson K, Macgillivray K, Young C, Hancock J, Redwood S, Thomas M. Transaortic Transcatheter Aortic valve implantation using Edwards Sapien valve: a novel approach. Catheter Cardiovasc Interv. 2012 Apr 1;79(5):733-40. doi: 10.1002/ccd.23276. Epub 2011 Sep 26.
Background: PubMed 22464036Modine T, Sudre A, Delhaye C, Fayad G, Lemesle G, Collet F, Koussa M. Transcutaneous aortic valve implantation using the left carotid access: feasibility and early clinical outcomes. Ann Thorac Surg. 2012 May;93(5):1489-94. doi: 10.1016/j.athoracsur.2012.01.030. Epub 2012 Mar 28.
Background: PubMed 24814495Greenbaum AB, O'Neill WW, Paone G, Guerrero ME, Wyman JF, Cooper RL, Lederman RJ. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2795-804. doi: 10.1016/j.jacc.2014.04.015. Epub 2014 May 7.
Background: PubMed 26543600Schofer N, Deuschl F, Conradi L, Lubos E, Schirmer J, Reichenspurner H, Blankenberg S, Treede H, Schafer U. Preferential short cut or alternative route: the transaxillary access for transcatheter aortic valve implantation. J Thorac Dis. 2015 Sep;7(9):1543-7. doi: 10.3978/j.issn.2072-1439.2015.07.27.
Background: PubMed 22019110Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011 Nov 8;58(20):2130-8. doi: 10.1016/j.jacc.2011.08.050. Epub 2011 Oct 20.
Background: PubMed 29314570Amat-Santos IJ, Rojas P, Gutierrez H, Vera S, Castrodeza J, Tobar J, Goncalves-Ramirez LR, Carrasco M, Catala P, San Roman JA. Transubclavian approach: A competitive access for transcatheter aortic valve implantation as compared to transfemoral. Catheter Cardiovasc Interv. 2018 Nov 1;92(5):935-944. doi: 10.1002/ccd.27485. Epub 2018 Jan 3.
Background: PubMed 24485611Garcia DC, Benjo A, Cardoso RN, Macedo FY, Chavez P, Aziz EF, Herzog E, Alam M, de Marchena E. Device stratified comparison among transfemoral, transapical and transubclavian access for Transcatheter Aortic Valve Replacement (TAVR): a meta-analysis. Int J Cardiol. 2014 Mar 15;172(2):e318-21. doi: 10.1016/j.ijcard.2013.12.162. Epub 2014 Jan 9. No abstract available.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Stenosis

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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis, run by Ignacio J. Amat Santos at 1 site in Spain.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Oct 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

30-day death, stroke or embolic events, PVE or sepsis (time frame: 30 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04274751, which also lists 14 linked publications.

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 26 Oct 2021.