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

NCT05672823 | Completed DMC

• 1 other identifier: NL80895.091.22
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 8

Brief 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 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.

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter Aortic Valve Replacement; Coronary angiography; Hemorrhage; Hospitalization; Pacemaker

Outcome Measures

Primary Outcomes (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.

  "Through 30 days"

Secondary Outcomes (12)

• Time to mobilization

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

• Total duration of hospitalization

  "during index hospitalization, approximately 3 days"

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

  "Through 30 days"

• Clinically relevant bleeding not related to the randomized access sites

  "Through 30 days"

• All-cause mortality

  "30 days"

Other Outcomes (7)

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

  "Immediately after procedure"

• Fluoroscopy time

  "Immediately after procedure"

• Skin-to-skin time

  "Immediately after procedure"

Study Arms (2)

Minimally invasive, upper extremity

EXPERIMENTAL

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)

Lower extremity

ACTIVE COMPARATOR

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)

Interventions

Transcatheter Aortic Valve Implantation (TAVI) PROCEDURE

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

Lower extremity; Minimally invasive, upper extremity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Medtronic: collaborator

Study Sites (8)

Radboud university medical center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Maastricht UMC

Maastricht, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Isala Zwolle

Zwolle, Netherlands

Location

Related Publications (2)

• 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 Jan 13. doi: 10.1002/ccd.70470. Online ahead of print.

  PMID: 41527810 DERIVED

• 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.

  PMID: 39412806 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Hemorrhage

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Niels van Royen, prof. dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor, being the trial statistician, is blinded for the treatment groups. Groups are defined as group A and B during the preparation of the statistical tests. Only after performing the required statistical tests the data will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: November 28, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

NL (8)