Comparison Between Manta and Prostar Closure Devices

Study Overview
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Brief Summary
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Use of the closure device in patient with percutaneous transfemoral aortic valve replacement

Detailed Description
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The advent of endovascular, transcatheter aortic valve replacement (TAVR), and mechanical circulatory support has offered new, minimally invasive therapeutic options that are rapidly becoming standard of care. These percutaneous transfemoral interventions require large-bore catheters and have created challenges for femoral arterial access management. Current approaches include surgical cut-down with arterial puncture under direct vision, and suture-based pre-closure. Surgical cut-down is associated with longer procedural time, increased patient discomfort, deeper anesthesia, risk of wound complications including infection, and slower ambulation. The pre-closure technique overcomes many of the disadvantages of surgical cut-down but can be technically demanding, time consuming, and associated with a significant failure rate. Recent randomized TAVR trials have reported major vascular complications in 6% to 8% . Furthermore, a study on the 2 suture-based closure techniques for management of TAVR access reported a 20% vascular complication rate despite being used by experienced operators . Currently, the majority of access site complications result from failed arteriotomy closure . The percutaneous MANTA Vascular Closure Device (VCD) (Essential Medical Inc., Malvern, Pennsylvania) is a novel collagen-based technology dedicated to closure of largebore arteriotomies . The MANTA VCD underwent prospective multicenter evaluation for Conformitä Europäenne (CE) mark approval in the first detailed report of outcomes achieved with a dedicated large-bore vascular closure device Contrary to the aforementioned TAVR procedures, mechanical circulatory support therapy can be extended up to several days on the intensive care ward. Data on such delayed closure with is lacking. This registry is therefore aimed to document the initial experiences of delayed closure of a femoral large bore access with vascular closure devices in patients with an TAVR device.

Official Title
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Use of the Closure Device in Patient With Percutaneous Transfemoral Aortic Valve Replacement

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Transfemoral aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for treatment with the TAVR device 2. Decision to use the Manta or the Prostar closure device on a clinical base by the treating physician 3. Signed informed consent Exclusion Criteria: Male or female aged < 18 2. Pregnant and lactating females 3. Patient has been committed to an institution by legal or regulatory order

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pro Star<br>patient received Pro Star Device | Device: Transfemoral aortic valve replacement<br>* aortic valve replacement<br>|
| MANTA<br>Patient received MANTA Device | Device: Transfemoral aortic valve replacement<br>* aortic valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints during index hospitalisation | Major vascular complications, | 2018 - 2020 | 
| Safety endpoints during index hospitalisation ( bleeding) | life-threatining-, major bleeding | 2018-2020 | 
| Safety endpoints during index hospitalisation ( death ) | death | 2018-2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy endpoints during index hospitalisation - (hemotasis) | hemotasis in angiogram | 2018-2020 | 
| efficacy endpoints during index hospitalisation ( device failure) | device failure | 2018-2020 | 
| efficacy endpoints during index hospitalisation ( bail-out ) | need for stent-graft | 2018-2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closure