Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.

Detailed Description
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Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.

Official Title
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Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Manta
* Device: ProGlide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an indication for transfemoral TAVI as judged by the local heart team. Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team. The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations. Exclusion Criteria: Vascular access site anatomy not suitable for percutaneous vascular closure. Vascular access site complications prior to the TAVI procedure. Known allergy or hypersensitivity to any VCD component. Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia. Absence of computed tomographic data of the access site before the procedure. Systemic infection or a local infection at or near the access site. Life expectancy of less than 6 months due to non-cardiac conditions. Patient cannot adhere to or complete the investigational protocol for any reason. Pregnant or nursing subjects. Participation in any other interventional trial.

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
Interventional Model Description: Investigator-initiated, single-center, prospective, open-label randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manta<br>plug-based vascular closure | Device: Manta<br>* plug-based vascular closure<br>|
| Active Comparator: ProGlide<br>suture-based vascular closure | Device: ProGlide<br>* suture-based vascular closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition | Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of access-site or access-related vascular injury | Rate of access-site or access-related vascular injury | 30 days | 
| Rate of major access-site or access-related vascular injury | Rate of major access-site or access-related vascular injury | up to 7 days and at 30 days | 
| Rate of minor access site or access-related vascular injury | Rate of minor access site or access-related vascular injury | up to 7 days and at 30 days | 
| Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria | Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria | up to 7 days and at 30 days) | 
| all-cause death | all-cause death | up to 7 days and 30-day | 
| death attributed to access-site or access-related complications | death attributed to access-site or access-related complications | up to 7 days and 30-day | 
| Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site | Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other | up to 7 days | 
| access-site or access-related disabling/life- threatening bleeding according to BARC | access-site or access-related disabling/life- threatening bleeding according to BARC | up to 7 days and 30-day | 
| access-site or access-related major bleeding according to BARC | access-site or access-related major bleeding according to BARC | up to 7 days and 30-day | 
| access-site or access-related minor bleeding according to BARC | access-site or access-related minor bleeding according to BARC | up to 7 days and 30-day | 
| Need for blood transfusion for access-site or access-related bleeding or vascular complications | Need for blood transfusion for access-site or access-related bleeding or vascular complications | up to 7 days | 
| Total number of blood transfusions because of access-site or access-related bleeding | Total number of blood transfusions because of access-site or access-related bleeding | up to 7 days | 
| Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis | Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis | 24 hours | 
| Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment | Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment | 24 hours | 
| Length of postprocedural hospital stay | Length of postprocedural hospital stay | up to 7 days | 
| Time to hemostasis, defined as the time from VCD application to complete hemostasis | Time to hemostasis, defined as the time from VCD application to complete hemostasis | 24 hours | 
| Need and number of additional unplanned VCDs | Need and number of additional unplanned VCDs | 24 hours | 
| Percent diameter stenosis of vascular access vessel on post-procedural angiography | Percent diameter stenosis of vascular access vessel on post-procedural angiography | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular access site closure, Transcatheter aortic valve implantation, Vascular closure device, Vascular access-site injury