Aortic Valve Stenosis
Conditions
Keywords
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation (TAVI), Vascular Closure Device
Brief summary
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 description
Detailed information is provided elsewhere.
Interventions
DEVICECombination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).
Combined suture- and plug-based VCD strategy after TF-TAVI.
DEVICECombination of two ProGlides or ProStyles (Abbott Vascular).
Pure suture-based VCD strategy after TF-TAVI.
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and able to give consent * Patients with an indication for TF-TAVI as judged by the local multi-disciplinary heart team * Feasibility of transfemoral access route using commercially available transcatheter heart valves and delivery systems * Written informed consent
Exclusion criteria
* Vascular access site anatomy not suitable for percutaneous vascular closure device * Vascular access site complications prior to the TAVI procedure * Known allergy or hypersensitivity to any component of the VCD * Active bleeding or bleeding diathesis * Absence of computed tomographic data of the access site before the procedure * Systemic infection or local infection at or near the access site * Limited long-term prognosis due to other comorbid conditions * Patient cannot adhere to or complete the trial protocol for any reason * Pregnancy * Participation in any other interventional trial * Patients with mechanical heart valves in mitral position * Patients with elevated international normalized ratio (INR) due to oral anticoagulation therapy requiring reversal of vitamin K antagonists prior to TAVI using prothrombin complex concentrate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis. | In-hospital, in average three days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | In-hospital (in average three days) and at 30-day follow-up | Individual components of the primary endpoint according to VARC-3 criteria. |
| Unplanned use of endovascular 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 | Unplanned use of endovascular stent (e.g. covered stent) and/or vascular surgery or other endovascular interventions at the puncture site. |
| Any bleedings. | In-hospital (in average three days) and at 30-day follow-up | Any type of bleedings according to VARC-3 criteria. |
| Need for blood transfusions. | In-hospital (in average three days) | Need for blood transfusions for vascular access-site-related bleedings or vascular complications. |
| Major or minor vascular and access-site-related complications after TF-TAVI. | At 30-day follow-up | Combination of major or minor vascular and access-site-related complications after TF-TAVI according to VARC-3 criteria. |
| All-cause mortality. | In-hospital (in average three days) and at 30-day follow-up | All-cause mortality according to VARC-3 criteria. |
| Length of post-procedural hospital stay. | In-hospital (in average three days) | Length of post-procedural hospital stay (days). |
| Time from VCD application to complete hemostasis. | Intra-procedural | Time from VCD application to complete hemostasis (seconds). |
| Percent diameter stenosis of vascular access vessel. | Intra-procedural | Percent diameter stenosis of vascular access vessel on post-procedural angiography. |
Countries
Germany
Outcome results
None listed