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

Study Overview
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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.

Official Title
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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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: Transcatheter Aortic Valve Implantation (TAVI)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive, upper extremity<br>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)<br>* Comparing different accessory access sites for TAVI: the temporary pacemaker access site and the diagnostic access site.<br>|
| Active Comparator: Lower extremity<br>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)<br>* Comparing different accessory access sites for TAVI: the temporary pacemaker access site and the diagnostic access site.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Aortic Valve Replacement, Coronary angiography, Hemorrhage, Hospitalization, Pacemaker