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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 238
- Locations
- 8
- Primary Endpoint
- Clinically relevant bleeding of the randomized access site; either diagnostic or pacemaker access site, or both
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Transcatheter Aortic Valve Implantation (TAVI) (Procedure)
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.
Intervention: Transcatheter Aortic Valve Implantation (TAVI) (Procedure)
Outcomes
Primary Outcomes
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
- Moderate or severe aortic regurgitation("30 days")
- Clinically relevant bleeding not related to the randomized access sites("Through 30 days")
- Valve Academic Research Consortium-3 (VARC) type 2-4 bleeding("30 days")
- 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")
- All-cause mortality("30 days")
- All stroke("30 days")
- Acute kidney injury stage 3 or 4("30 days")
- Surgery or intervention related to the device("30 days")
- Time to mobilization("during index hospitalization, approximately 3 days - often hours after TAVI procedure")
- Major vascular, access-related, or cardiac structural complications("30 days")
- New permanent pacemaker due to procedure-related conduction abnormalities("30 days")