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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.
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manta | Active Comparator | plug-based vascular closure |
|
| ProGlide | Active Comparator | suture-based vascular closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manta | Device | plug-based vascular closure |
| |
| ProGlide |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Abdel-Wahab, PD Dr. | Herzzentrum Leipzig GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herzzentrum Leipzig | Leipzig | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34738828 | Derived | Abdel-Wahab M, Hartung P, Dumpies O, Obradovic D, Wilde J, Majunke N, Boekstegers P, Muller R, Seyfarth M, Vorpahl M, Kiefer P, Noack T, Leontyev S, Sandri M, Rotta Detto Loria J, Kitamura M, Borger MA, Funkat AK, Hohenstein S, Desch S, Holzhey D, Thiele H; CHOICE-CLOSURE Investigators. Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial. Circulation. 2022 Jan 18;145(3):170-183. doi: 10.1161/CIRCULATIONAHA.121.057856. Epub 2021 Nov 5. |
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Investigator-initiated, single-center, prospective, open-label randomized controlled trial
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| Device |
suture-based vascular closure |
|
| 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 |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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