Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation

Helios Health Institute GmbH1 site in 1 country516 target enrollmentJune 26, 2020

ConditionsAortic Valve Stenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Helios Health Institute GmbH
Enrollment: 516
Locations: 1
Primary Endpoint: Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 26, 2020

End Date

August 4, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Helios Health Institute GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with an indication for transfemoral TAVI as judged by the local heart team.
•Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
•The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.

Exclusion Criteria

•Vascular access site anatomy not suitable for percutaneous vascular closure.
•Vascular access site complications prior to the TAVI procedure.
•Known allergy or hypersensitivity to any VCD component.
•Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
•Absence of computed tomographic data of the access site before the procedure.
•Systemic infection or a local infection at or near the access site.
•Life expectancy of less than 6 months due to non-cardiac conditions.
•Patient cannot adhere to or complete the investigational protocol for any reason.
•Pregnant or nursing subjects.
•Participation in any other interventional trial.

Outcomes

Primary Outcomes

Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition

Time Frame: up to 7 days

Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition

Secondary Outcomes

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(30 days)
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site(up to 7 days)
Rate of major access-site or access-related vascular injury(up to 7 days and at 30 days)
death attributed to access-site or access-related complications(up to 7 days and 30-day)
Time to hemostasis, defined as the time from VCD application to complete hemostasis(24 hours)
access-site or access-related disabling/life- threatening bleeding according to BARC(up to 7 days and 30-day)
all-cause death(up to 7 days and 30-day)
access-site or access-related minor bleeding according to BARC(up to 7 days and 30-day)
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis(24 hours)
Percent diameter stenosis of vascular access vessel on post-procedural angiography(24 hours)
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))
access-site or access-related major bleeding according to BARC(up to 7 days and 30-day)
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)
Total number of blood transfusions because of access-site or access-related bleeding(up to 7 days)
Length of postprocedural hospital stay(up to 7 days)
Need and number of additional unplanned VCDs(24 hours)
Need for blood transfusion for access-site or access-related bleeding or vascular complications(up to 7 days)