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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.
see summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MANTA vascular closure device | Active Comparator | Arteriotomy closure with a collagen-based vascular closure device (MANTA™) |
|
| Suture based vascular closure device | Active Comparator | Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MANTA vascular closure device | Device | Collagen based vascular closure device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas M Van Mieghem, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Center Rotterdam | Rotterdam | 3000 CA | Netherlands |
no sharing of individual data (no permission from participants. GDPR)
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Open label randomized trial
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| Suture based vascular closure device | Device | Suture based vascular closure device (ProGlide) |
|
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 |
| D014694 |
| Ventricular Outflow Obstruction |