Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial

Study Overview
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Brief Summary
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To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve replacement.

Detailed Description
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see summary

Official Title
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MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: MANTA vascular closure device
* Device: Suture based vascular closure device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV) Common femoral artery diameter > 5.0mm (14 - 22F compatible) Exclusion Criteria: Symptomatic leg ischaemia Previous thromboendarterectomy or plastic patch of the common femoral artery Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months Unilateral or bilateral lower extremity amputation Systemic infection or a local infection at or near the access site Allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel) Active bleeding or bleeding diathesis including thrombocytopenia (platelet count <50,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease Patients in whom continuous oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR >1.8 at the time of the procedure Patient unable to be adequately anti-coagulated for the procedure Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2) Anatomical and procedural contraindication for suture-based or Manta closure (lack of proper puncture site in the common femoral artery in terms of calcification, size, and atherosclerotic disease) Absence of computed tomographic data of the access site before the procedure Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease Known pregnancy at time of randomization (in women of childbearing potential a negative pregnancy test is mandatory) Participating in trials in which the primary endpoint includes bleeding or vascular complications

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: Open label randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MANTA vascular closure device<br>Arteriotomy closure with a collagen-based vascular closure device (MANTA™) | Device: MANTA vascular closure device<br>* Collagen based vascular closure device<br>|
| Active Comparator: Suture based vascular closure device<br>Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide) | Device: Suture based vascular closure device<br>* Suture based vascular closure device (ProGlide)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite rate of major- and minor vascular complications according to VARC-2 | The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up. | Between transcatheter aortic valve implantation and 30 days follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with a Major Vascular Complication according to VARC-2 | total number of participants major vascular complications | Between transcatheter aortic valve implantation and 30 days follow-up | 
| Number of Participants with a Minor Vascular Complication according to VARC-2 | total number of participants minor vascular complications | Between transcatheter aortic valve implantation and 30 days follow-up | 
| All-cause death rate | A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made | Between transcatheter aortic valve implantation and 30 days follow-up | 
| Number of Participants with a major- or life threatening bleeding according to VARC-2 | total number of participants with major/life-threatening bleedings | Between transcatheter aortic valve implantation and 30 days follow-up | 
| Need for transfusions for access site related bleeding/complications | Total number of transfusions of RBC because of site-related bleeding | Between transcatheter aortic valve implantation and 30 days follow-up | 
| Number of Participants with vascular closure device failure | Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning) | Between transcatheter aortic valve implantation and 30 days follow-up | 
| Time to hemostasis | After the use of a vascular closure device the time to hemostasis will be classified as immediate hemostasis, hemostasis after 5 minutes manual compression, hemostasis after 10 minutes manual compression, hemostasis after endovascular ballooning, hemostasis after endovascular intervention or hemostasis after surgical intervention | During the TAVI procedure | 
| Total procedure time | The total procedural time in minutes will be compared between the two treatment arms | During the TAVI procedure | 
| Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5 | Clinically relevant bleeding defined as BARC 2, 3 and 5 | Between transcatheter aortic valve implantation and 30 days follow-up | 
| Length of hospital stay | The total length of hospital stay in days will be compared between the two treatment arms | Up to a maximum of 30 days after the TAVI procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Closure Devices, Transcatheter Aortic Valve Implantation