MASH-TAVI: Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
see summary
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: MANTA vascular closure device Arteriotomy closure with a collagen-based vascular closure device (MANTA™) |
Device: MANTA vascular closure device
Collagen based vascular closure device
|
| Active Comparator: Suture based vascular closure device Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide) |
Device: Suture based vascular closure device
Suture based vascular closure device (ProGlide)
|
Outcome Measures
Primary Outcome Measures
- Composite rate of major- and minor vascular complications according to VARC-2 [Between transcatheter aortic valve implantation and 30 days follow-up]
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.
Secondary Outcome Measures
- Number of Participants with a Major Vascular Complication according to VARC-2 [Between transcatheter aortic valve implantation and 30 days follow-up]
total number of participants major vascular complications
- Number of Participants with a Minor Vascular Complication according to VARC-2 [Between transcatheter aortic valve implantation and 30 days follow-up]
total number of participants minor vascular complications
- All-cause death rate [Between transcatheter aortic valve implantation and 30 days follow-up]
A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made
- Number of Participants with a major- or life threatening bleeding according to VARC-2 [Between transcatheter aortic valve implantation and 30 days follow-up]
total number of participants with major/life-threatening bleedings
- Need for transfusions for access site related bleeding/complications [Between transcatheter aortic valve implantation and 30 days follow-up]
Total number of transfusions of RBC because of site-related bleeding
- Number of Participants with vascular closure device failure [Between transcatheter aortic valve implantation and 30 days follow-up]
Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)
- Time to hemostasis [During the TAVI procedure]
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
- Total procedure time [During the TAVI procedure]
The total procedural time in minutes will be compared between the two treatment arms
- Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5 [Between transcatheter aortic valve implantation and 30 days follow-up]
Clinically relevant bleeding defined as BARC 2, 3 and 5
- Length of hospital stay [Up to a maximum of 30 days after the TAVI procedure]
The total length of hospital stay in days will be compared between the two treatment arms
Eligibility Criteria
Criteria
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
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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
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Patient unable to be adequately anti-coagulated for the procedure
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Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
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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)
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Absence of computed tomographic data of the access site before the procedure
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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)
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Participating in trials in which the primary endpoint includes bleeding or vascular complications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus University Medical Center Rotterdam | Rotterdam | Netherlands | 3000 CA |
Sponsors and Collaborators
- Erasmus Medical Center
Investigators
- Principal Investigator: Nicolas M Van Mieghem, MD, PhD, Erasmus Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MASH TAVI 06-09-2018