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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Procedure | Comparing different accessory access sites for TAVI: the temporary pacemaker access site and the diagnostic access site. |
| 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" |
| 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" |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency rate of cross-over to the non-randomized access site | Frequency rate of cross-over of either the diagnostic or temporary pacemaker access site, or both. | "Immediately after procedure" |
| Fluoroscopy time |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels van Royen, prof. dr. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university medical center | Nijmegen | Gelderland | 6525GA | Netherlands | ||
| Amsterdam UMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41527810 | Derived | 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 Apr;107(5):1293-1302. doi: 10.1002/ccd.70470. Epub 2026 Jan 13. | |
| 39412806 |
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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.
| Total duration of hospitalization |
Duration of index hospitalization in days. |
| "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 | Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding of either the diagnostic access, pacemaker access or primary (TAVI) access. | "Through 30 days" |
| Clinically relevant bleeding not related to the randomized access sites | Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding not related to the diagnostic access or pacemaker access. | "Through 30 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:
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" |
Fluoroscopy time during the procedure measured in minutes.
| "Immediately after procedure" |
| Skin-to-skin time | Skin-to-skin time of the total procedure measured in minutes. | "Immediately after procedure" |
| Number of punctions for diagnostic access | The number of punctions before secondary arterial (diagnostic) access was achieved. | "Immediately after procedure" |
| Number of punctions for temporary pacemaker access | The number of punctions before temporary pacemaker access was achieved. | "Immediately after procedure" |
| Temporary pacemaker failure | Defined as either:
| "during index hospitalization, approximately 3 days" |
| Pacemaker lead in situ duration | The duration for which the temporary pacemaker wire was in situ in minutes. | "during index hospitalization, approximately 3 days" |
| Amsterdam |
| Netherlands |
| OLVG | Amsterdam | Netherlands |
| Amphia Ziekenhuis | Breda | Netherlands |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Maastricht UMC | Maastricht | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Isala Zwolle | Zwolle | Netherlands |
| 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. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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