Clinical trial NCT05672823: Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Replacement
Coronary angiography
Hemorrhage
Hospitalization
Pacemaker
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2023-01-05
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinically relevant bleeding of the randomized access site; either diagnostic or pacemaker access site, or both
timeFrame: "Through 30 days"
Secondary outcomes:
measure: Time to mobilization
timeFrame: "during index hospitalization, approximately 3 days - often hours after TAVI procedure"
measure: Total duration of hospitalization
timeFrame: "during index hospitalization, approximately 3 days"
measure: Composite endpoint of all clinically relevant bleeding of the access sites; either diagnostic or pacemaker access site or primary (TAVI) access site
timeFrame: "Through 30 days"
measure: Clinically relevant bleeding not related to the randomized access sites
timeFrame: "Through 30 days"
measure: All-cause mortality
timeFrame: "30 days"
measure: All stroke
timeFrame: "30 days"
measure: Valve Academic Research Consortium-3 (VARC) type 2-4 bleeding
timeFrame: "30 days"
measure: Major vascular, access-related, or cardiac structural complications
timeFrame: "30 days"
measure: Acute kidney injury stage 3 or 4
timeFrame: "30 days"
measure: Moderate or severe aortic regurgitation
timeFrame: "30 days"
measure: New permanent pacemaker due to procedure-related conduction abnormalities
timeFrame: "30 days"
measure: Surgery or intervention related to the device
timeFrame: "30 days"
Other outcomes:
measure: Frequency rate of cross-over to the non-randomized access site
timeFrame: "Immediately after procedure"
measure: Fluoroscopy time
timeFrame: "Immediately after procedure"
measure: Skin-to-skin time
timeFrame: "Immediately after procedure"
measure: Number of punctions for diagnostic access
timeFrame: "Immediately after procedure"
measure: Number of punctions for temporary pacemaker access
timeFrame: "Immediately after procedure"
measure: Temporary pacemaker failure
timeFrame: "during index hospitalization, approximately 3 days"
measure: Pacemaker lead in situ duration
timeFrame: "during index hospitalization, approximately 3 days"
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Amsterdam
country: Netherlands
facility: OLVG
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Zwolle
Study officials:
affiliation: Radboud University Medical Center
name: Niels van Royen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: