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Completed

NCT Number: NCT05672823

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

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:

* 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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud university medical center, Nijmegen, Gelderland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Transcatheter Aortic Valve Implantation (TAVI)

Procedure

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

Primary outcomes

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

    Time frame: "Through 30 days"

    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.

Secondary outcomes

  1. Time to mobilization

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

    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.

  2. Total duration of hospitalization

    Time frame: "during index hospitalization, approximately 3 days"

    Duration of index hospitalization in days.

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

    Time frame: "Through 30 days"

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

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

    Time frame: "Through 30 days"

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

  5. All-cause mortality

    Time frame: "30 days"

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

  6. All stroke

    Time frame: "30 days"

    All cerebrovascular accidents within the first 30 days after procedure.

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

    Time frame: "30 days"

    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.

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

    Time frame: "30 days"

    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.

  9. Acute kidney injury stage 3 or 4

    Time frame: "30 days"

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

  10. Moderate or severe aortic regurgitation

    Time frame: "30 days"

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

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

    Time frame: "30 days"

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

  12. Surgery or intervention related to the device

    Time frame: "30 days"

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

Other outcomes

  1. Frequency rate of cross-over to the non-randomized access site

    Time frame: "Immediately after procedure"

    Frequency rate of cross-over of either the diagnostic or temporary pacemaker access site, or both.

  2. Fluoroscopy time

    Time frame: "Immediately after procedure"

    Fluoroscopy time during the procedure measured in minutes.

  3. Skin-to-skin time

    Time frame: "Immediately after procedure"

    Skin-to-skin time of the total procedure measured in minutes.

  4. Number of punctions for diagnostic access

    Time frame: "Immediately after procedure"

    The number of punctions before secondary arterial (diagnostic) access was achieved.

  5. Number of punctions for temporary pacemaker access

    Time frame: "Immediately after procedure"

    The number of punctions before temporary pacemaker access was achieved.

  6. Temporary pacemaker failure

    Time frame: "during index hospitalization, approximately 3 days"

    Defined as either:

    • Failure to capture
    • Failure to pace
    • Failure to sense intrinsic beats

  7. Pacemaker lead in situ duration

    Time frame: "during index hospitalization, approximately 3 days"

    The duration for which the temporary pacemaker wire was in situ in minutes.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Medtronic

Registry information

Official study 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

Acronym: TAVIXS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2023
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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