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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2023-12-15

Brief Summary

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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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Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Transcatheter Aortic Valve Implantation (TAVI)

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Transcatheter Aortic Valve Implantation (TAVI)

Intervention Type PROCEDURE

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

Interventions

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Transcatheter Aortic Valve Implantation (TAVI)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No