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

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:

• 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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: Transcatheter Aortic Valve Implantation (TAVI)

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • OLVG
  • Amsterdam, Netherlands
    • Amsterdam UMC
  • Breda, Netherlands
    • Amphia ziekenhuis
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis
  • Maastricht, Netherlands
    • Maastricht UMC
  • Nieuwegein, Netherlands
    • St. Antonius ziekenhuis
  • Zwolle, Netherlands
    • Isala Zwolle
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lower extremity; Femoral 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.	Procedure: Transcatheter Aortic Valve Implantation (TAVI); Comparing different accessory access sites for TAVI: the temporary pacemaker access site and the diagnostic access site.
Experimental: Minimally invasive, upper extremity; Radial 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.	Procedure: Transcatheter Aortic Valve Implantation (TAVI); Comparing different accessory access sites for TAVI: the temporary pacemaker access site and the diagnostic access site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	"Through 30 days"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	"during index hospitalization, approximately 3 days - often hours after TAVI procedure"
Total duration of hospitalization	Duration of index hospitalization in days.	"during index hospitalization, approximately 3 days"
All-cause mortality	Deaths within the first 30 days after procedure from any cause.	"30 days"
All stroke	All cerebrovascular accidents within the first 30 days after procedure.	"30 days"
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.	"30 days"
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.	"30 days"
Acute kidney injury stage 3 or 4	All cases of acute kidney injury stage 3 or 4 within 30 days after procedure.	"30 days"
Moderate or severe aortic regurgitation	All cases of moderate or severe aortic regurgitation within 30 days after procedure.	"30 days"
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.	"30 days"
Surgery or intervention related to the device	All cases of surgery or interventions related to the device within 30 days after procedure.	"30 days"
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.	"Through 30 days"
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.	"Through 30 days"

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency rate of cross-over to the non-randomized access site	Frequency rate of cross-over of either the diagnostic or temporary pacemaker access site, or both.	"Immediately after procedure"
Fluoroscopy time	Fluoroscopy time during the procedure measured in minutes.	"Immediately after procedure"
Skin-to-skin time	Skin-to-skin time of the total procedure measured in minutes.	"Immediately after procedure"
Temporary pacemaker failure	Defined as either: Failure to capture; Failure to pace; Failure to sense intrinsic beats	"during index hospitalization, approximately 3 days"
Number of punctions for diagnostic access	The number of punctions before secondary arterial (diagnostic) access was achieved.	"Immediately after procedure"
Number of punctions for temporary pacemaker access	The number of punctions before temporary pacemaker access was achieved.	"Immediately after procedure"
Pacemaker lead in situ duration	The duration for which the temporary pacemaker wire was in situ in minutes.	"during index hospitalization, approximately 3 days"

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: Niels van Royen, prof. dr., Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 3, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Coronary angiography; Transcatheter Aortic Valve Replacement; Hemorrhage; Pacemaker; Hospitalization
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: NL80895.091.22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No