Clinical trial NCT04459208: Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
Official title: Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Vascular access site closure
Transcatheter aortic valve implantation
Vascular closure device
Vascular access-site injury
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator-initiated, single-center, prospective, open-label randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
timeFrame: up to 7 days
Secondary outcomes:
measure: Rate of access-site or access-related vascular injury
timeFrame: 30 days
measure: Rate of major access-site or access-related vascular injury
timeFrame: up to 7 days and at 30 days
measure: Rate of minor access site or access-related vascular injury
timeFrame: up to 7 days and at 30 days
measure: Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
timeFrame: up to 7 days and at 30 days)
measure: all-cause death
timeFrame: up to 7 days and 30-day
measure: death attributed to access-site or access-related complications
timeFrame: up to 7 days and 30-day
measure: Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
timeFrame: up to 7 days
measure: access-site or access-related disabling/life- threatening bleeding according to BARC
timeFrame: up to 7 days and 30-day
measure: access-site or access-related major bleeding according to BARC
timeFrame: up to 7 days and 30-day
measure: access-site or access-related minor bleeding according to BARC
timeFrame: up to 7 days and 30-day
measure: Need for blood transfusion for access-site or access-related bleeding or vascular complications
timeFrame: up to 7 days
measure: Total number of blood transfusions because of access-site or access-related bleeding
timeFrame: up to 7 days
measure: Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
timeFrame: 24 hours
measure: Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
timeFrame: 24 hours
measure: Length of postprocedural hospital stay
timeFrame: up to 7 days
measure: Time to hemostasis, defined as the time from VCD application to complete hemostasis
timeFrame: 24 hours
measure: Need and number of additional unplanned VCDs
timeFrame: 24 hours
measure: Percent diameter stenosis of vascular access vessel on post-procedural angiography
timeFrame: 24 hours
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
Study officials:
affiliation: Herzzentrum Leipzig GmbH
name: Mohamed Abdel-Wahab, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.