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The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.
Detailed information is provided elsewhere.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined suture- and plug-based VCD strategy | Experimental | 1 ProGlide or ProStyle + 1 Angio-Seal |
|
| Pure suture-based VCD strategy | Experimental | 2 ProGlides or ProStyles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo). | Device | Combined suture- and plug-based VCD strategy after TF-TAVI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis. | The primary outcome measure is a combination of major or minor vascular and access-site-related complications or need for additional interventional (e.g. covered stent implantation) or surgical procedures related to vascular hemostasis according to updated VARC-3 criteria. | In-hospital, in average three days |
| Measure | Description | Time Frame |
|---|---|---|
| Major or minor vascular and access-site-related complications after TF-TAVI. | Combination of major or minor vascular and access-site-related complications after TF-TAVI according to VARC-3 criteria. | At 30-day follow-up |
| Individual components of the primary endpoint, namely 1) major or minor vascular and access-site-related complications, 2) need for additional interventional or surgical procedures related to vascular hemostasis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Joner, MD | Deutsches Herzzentrum München | Principal Investigator |
| Tobias Rheude, MD | Deutsches Herzzentrum München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum München | Munich | Bavaria | 80636 | Germany |
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| Combination of two ProGlides or ProStyles (Abbott Vascular). | Device | Pure suture-based VCD strategy after TF-TAVI. |
|
Individual components of the primary endpoint according to VARC-3 criteria. |
| In-hospital (in average three days) and at 30-day follow-up |
| Unplanned use of endovascular stent and/or vascular surgery or other endovascular interventions at the puncture site. | Unplanned use of endovascular stent (e.g. covered stent) and/or vascular surgery or other endovascular interventions at the puncture site. | In-hospital (in average three days) and at 30-day follow-up |
| Any bleedings. | Any type of bleedings according to VARC-3 criteria. | In-hospital (in average three days) and at 30-day follow-up |
| Need for blood transfusions. | Need for blood transfusions for vascular access-site-related bleedings or vascular complications. | In-hospital (in average three days) |
| Percent diameter stenosis of vascular access vessel. | Percent diameter stenosis of vascular access vessel on post-procedural angiography. | Intra-procedural |
| All-cause mortality. | All-cause mortality according to VARC-3 criteria. | In-hospital (in average three days) and at 30-day follow-up |
| Length of post-procedural hospital stay. | Length of post-procedural hospital stay (days). | In-hospital (in average three days) |
| Time from VCD application to complete hemostasis. | Time from VCD application to complete hemostasis (seconds). | Intra-procedural |
| 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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