AzTrials
AzTrials

Aortic Valve StenosisTAVIXSNCT05672823

Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation

A study testing Transcatheter Aortic Valve Implantation (TAVI) in people with Aortic Valve Stenosis, run by Radboud University Medical Center at 8 sites in Netherlands.

Completed

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

Official record
Search all trials

Trial summary

The goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach for accessory access sites in patients undergoing a transcatheter aortic valve… 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 (TAVI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
8 sitesNetherlands
Study dates
28 Nov 2022to 15 Dec 2023
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

  • Patients must be > 18 years old.
  • Written informed consent is obtained from all patients.
  • Planned for transfemoral TAVI procedure.

Who cannot join

  • Inability to obtain informed consent.
  • Contra-indication for brachial or femoral vein access (temporary pacemaker access site).
  • Contra-indication for radial or femoral artery access (diagnostic access site).
  • Use of a cerebral embolic protection device (CEPD) if this requires an additional (arterial) access site.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Netherlands8 sites

  • Amsterdam UMC

    Amsterdam

  • OLVG

    Amsterdam

  • Amphia Ziekenhuis

    Breda

  • Catharina Ziekenhuis

    Eindhoven

  • Maastricht UMC

    Maastricht

  • St. Antonius Ziekenhuis

    Nieuwegein

  • Radboud university medical center

    Nijmegen, Gelderland, 6525GA

  • Isala Zwolle

    Zwolle

Other trials in Netherlands

About this study

Official title: Minimally-Invasive Upper Extremity Approach Versus Lower Extremity Approach for Transcatheter Aortic Valve Implantation (TAVI) Accessory Access Sites; A Prospective, Multicenter, Investigator-Initiated, Randomized Clinical Trial

The goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach for accessory access sites in patients undergoing a transcatheter aortic valve implantation.

The main questions it aims to answer are whether a 'minimally invasive, upper extremity' approach as compared with the standard 'lower extremity' approach:

Read more
  • Is associated with less clinically relevant access site-related bleeding complications.
  • Is associated with a shorter time to mobilization after TAVI.
  • Is associated with a shorter duration of hospitalization.
  • Has the same early safety outcomes at 30 days post-TAVI.

Participants will be subject to the usual care surrounding a TAVI procedure but will also will be asked to fill out two questionnaires before and after TAVI:

  • Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)
  • Lower Extremity Functional Scale (LEFS)

Researchers will compare the minimally invasive, upper extremity group with the standard lower extremity to see if there are difference regarding the posed questions.

Being tested
Transcatheter Aortic Valve Implantation (TAVI)
Keywords
Transcatheter Aortic Valve Replacement, Coronary angiography, Hemorrhage, Hospitalization, Pacemaker
Medical subject headings
Aortic Valve Stenosis, Hemorrhage

What participants receive

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

  • Transcatheter Aortic Valve Implantation (TAVI)Procedure or surgery

    Comparing different accessory access sites for TAVI: the temporary pacemaker access site and the diagnostic access site.

Study groups in NCT05672823
Study groupRoleWhat they receive
Minimally invasive, upper extremityExperimentalRadial artery for pigtail catheter and pacing over the Left Ventricular (LV) stiff wire OR radial artery for pigtail catheter and brachial vein for temporary pacemaker when not pacing over the LV stiff wire.
Receives: Procedure: Transcatheter Aortic Valve Implantation (TAVI)
Lower extremityActive comparatorFemoral artery for pigtail catheter and pacing over the LV stiff wire OR femoral artery for pigtail catheter and femoral vein for temporary pacemaker when not pacing over the LV stiff wire.
Receives: Procedure: Transcatheter Aortic Valve Implantation (TAVI)

What is being measured

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

  1. Clinically relevant bleeding of the randomized access site; either diagnostic or pacemaker access site, or both

    Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding; In case a clinically relevant bleeding occurs in both the randomized diagnostic access site and the randomized pacemaker access site, these will be combined and the highest classification of the two BARC bleedings will be scored.

    BARC classification: a classification scoring bleeding complication based on the clinical actions that follow in which type 1 bleeding is not actionable and type 5 bleeding is fatal.

    Measured: "Through 30 days"

Secondary outcomes (12)

  1. Time to mobilization

    Time to first mobilization in minutes after procedure; mobilization is defined as walking short distances on the patients room or on the corridor. Transfers between bed and chair are not measured as mobilization.

    Measured: "during index hospitalization, approximately 3 days - often hours after TAVI procedure"

  2. Total duration of hospitalization

    Duration of index hospitalization in days.

    Measured: "during index hospitalization, approximately 3 days"

  3. Composite endpoint of all clinically relevant bleeding of the access sites; either diagnostic or pacemaker access site or primary (TAVI) access site

    Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding of either the diagnostic access, pacemaker access or primary (TAVI) access.

    Measured: "Through 30 days"

  4. Clinically relevant bleeding not related to the randomized access sites

    Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding not related to the diagnostic access or pacemaker access.

    Measured: "Through 30 days"

  5. All-cause mortality

    Deaths within the first 30 days after procedure from any cause.

    Measured: "30 days"

  6. All stroke

    All cerebrovascular accidents within the first 30 days after procedure.

    Measured: "30 days"

  7. Valve Academic Research Consortium-3 (VARC) type 2-4 bleeding

    Bleeding criteria following the VARC-3 criteria. Type 2 bleeding is classified as bleeding requiring transfusion. Type 3 bleeding is defined as bleeding in a critical organ, causing hypovolemic shock, requiring reoperation or significant transfusion.

    Type 4 bleeding is defined as overt bleeding leading to death.

    Measured: "30 days"

  8. Major vascular, access-related, or cardiac structural complications

    Major vascular complications:

    • Aortic dissection or aortic rupture.
    • Vascular (arterial or venous) injury, unplanned endovascular or surgical intervention, closure device failure, distal embolization or compartment syndrome resulting in death, VARC type ≥ 2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment.

    Major access-related complications:

    • Non-vascular structure, non-cardiac structure perforation, injury, or infection resulting in death, VARC type ≥ 2 bleeding, irreversible nerve injury or requiring unplanned surgery or percutaneous intervention

    Major cardiac structural complications:

    • Cardiac structure perforation, injury, new pericardial effusion, coronary obstruction or compromise resulting in death,VARC type ≥ 2 bleeding, haemodynamic compromise or tamponade, or requiring unplanned surgical or percutaneous intervention.

    Measured: "30 days"

  9. Acute kidney injury stage 3 or 4

    All cases of acute kidney injury stage 3 or 4 within 30 days after procedure.

    Measured: "30 days"

  10. Moderate or severe aortic regurgitation

    All cases of moderate or severe aortic regurgitation within 30 days after procedure.

    Measured: "30 days"

  11. New permanent pacemaker due to procedure-related conduction abnormalities

    All permanent pacemaker placements in the first 30 days after procedure due to procedure-related conduction abnormalities.

    Measured: "30 days"

  12. Surgery or intervention related to the device

    All cases of surgery or interventions related to the device within 30 days after procedure.

    Measured: "30 days"

Timeline

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

  1. First posted5 Jan 2023
  2. Study start28 Nov 2022
  3. Primary completion15 Dec 2023
  4. Study completion15 Dec 2023

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672823
Sponsor's protocol ID
NL80895.091.22
Acronym
TAVIXS
Status last verified
Feb 2024
First submitted
3 Jan 2023
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Versteeg GAA, Rooijakkers MJP, Hemelrijk KI, Vlaar PJ, Overduin DC, van Wely MH, Aarts HM, van Ginkel DJ, Stens NA, van Nunen LX, van Geuns RJ, van Garsse LAFM, Geuzebroek GSC, Verkroost MWA, Cetinyurek-Yavuz A, Heijmen RH, Thijssen DHJ, Ten Berg JM, Tonino PAL, Delewi R, van Royen N. Extremity Function After Transfemoral Transcatheter Aortic Valve Implantation: A TAVI XS Sub-Study. Catheter Cardiovasc Interv. 2026 Apr;107(5):1293-1302. doi: 10.1002/ccd.70470. Epub 2026 Jan 13.

    PubMed 41527810

  • Versteeg GAA, Rooijakkers MJP, Hemelrijk KI, Vlaar PJ, Overduin DC, van Wely MH, Aarts HM, van Ginkel DJ, van Nunen LX, van Geuns RJ, van Garsse LAFM, Geuzebroek GSC, Verkroost MWA, Cetinyurek-Yavuz A, Heijmen RH, Ten Berg JM, Tonino PAL, Delewi R, van Royen N. Upper- vs Lower-Extremity Secondary Access During Transcatheter Aortic Valve Implantation: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2438578. doi: 10.1001/jamanetworkopen.2024.38578.

    PubMed 39412806

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Aortic Valve Implantation (TAVI) in people with Aortic Valve Stenosis, run by Radboud University Medical Center at 8 sites in Netherlands.

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 4 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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Netherlands. 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?

Clinically relevant bleeding of the randomized access site; either diagnostic or pacemaker access site, or both (time frame: "Through 30 days"). 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 NCT05672823, which also lists 2 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 12 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in