Aortic Valve Stenosis
Conditions
Keywords
Vascular access site closure, Transcatheter aortic valve implantation, Vascular closure device, Vascular access-site injury
Brief summary
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.
Detailed description
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
Interventions
DEVICEManta
plug-based vascular closure
DEVICEProGlide
suture-based vascular closure
Sponsors
Helios Health Institute GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Investigator-initiated, single-center, prospective, open-label randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with an indication for transfemoral TAVI as judged by the local heart team. 2. Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team. 3. The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.
Exclusion criteria
1. Vascular access site anatomy not suitable for percutaneous vascular closure. 2. Vascular access site complications prior to the TAVI procedure. 3. Known allergy or hypersensitivity to any VCD component. 4. Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia. 5. Absence of computed tomographic data of the access site before the procedure. 6. Systemic infection or a local infection at or near the access site. 7. Life expectancy of less than 6 months due to non-cardiac conditions. 8. Patient cannot adhere to or complete the investigational protocol for any reason. 9. Pregnant or nursing subjects. 10. Participation in any other interventional trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition | up to 7 days | Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of major access-site or access-related vascular injury | up to 7 days and at 30 days | Rate of major 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 minor access site or access-related vascular injury |
| 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) | Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria |
| all-cause death | up to 7 days and 30-day | all-cause death |
| death attributed to access-site or access-related complications | up to 7 days and 30-day | death attributed to access-site or access-related complications |
| Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site | up to 7 days | Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other |
| access-site or access-related disabling/life- threatening bleeding according to BARC | up to 7 days and 30-day | access-site or access-related disabling/life- threatening 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 major bleeding according to BARC |
| Rate of access-site or access-related vascular injury | 30 days | Rate of access-site or access-related vascular injury |
| Need for blood transfusion for access-site or access-related bleeding or vascular complications | up to 7 days | Need for blood transfusion for access-site or access-related bleeding or vascular complications |
| Total number of blood transfusions because of access-site or access-related bleeding | up to 7 days | Total number of blood transfusions because of access-site or access-related bleeding |
| 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 success, defined as the ability of a closure device strategy to obtain hemostasis |
| 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 | Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment |
| Length of postprocedural hospital stay | up to 7 days | Length of postprocedural hospital stay |
| Time to hemostasis, defined as the time from VCD application to complete hemostasis | 24 hours | Time to hemostasis, defined as the time from VCD application to complete hemostasis |
| Need and number of additional unplanned VCDs | 24 hours | Need and number of additional unplanned VCDs |
| Percent diameter stenosis of vascular access vessel on post-procedural angiography | 24 hours | Percent diameter stenosis of vascular access vessel on post-procedural angiography |
| access-site or access-related minor bleeding according to BARC | up to 7 days and 30-day | access-site or access-related minor bleeding according to BARC |
Countries
Germany
Outcome results
None listed