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

Aortic Valve Stenosis Clinical Trial

— CHOICE-CLOSURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459208
• Other study ID #: 2020-0191
• Status: Completed
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: August 4, 2021

Study information

• Verified date: September 2021
• Source: Leipzig Heart Institute GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: August 4, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Manta
plug-based vascular closure
• ProGlide
suture-based vascular closure

Locations

Country	Name	City	State
Germany	Herzzentrum Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Leipzig Heart Institute GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition	Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition	up to 7 days
Secondary	Rate of access-site or access-related vascular injury	Rate of access-site or access-related vascular injury	30 days
Secondary	Rate of major access-site or access-related vascular injury	Rate of major access-site or access-related vascular injury	up to 7 days and at 30 days
Secondary	Rate of minor 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
Secondary	Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria	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)
Secondary	all-cause death	all-cause death	up to 7 days and 30-day
Secondary	death attributed to access-site or access-related complications	death attributed to access-site or access-related complications	up to 7 days and 30-day
Secondary	Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site	Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other	up to 7 days
Secondary	access-site or access-related disabling/life- threatening bleeding according to BARC	access-site or access-related disabling/life- threatening bleeding according to BARC	up to 7 days and 30-day
Secondary	access-site or access-related major bleeding according to BARC	access-site or access-related major bleeding according to BARC	up to 7 days and 30-day
Secondary	access-site or access-related minor bleeding according to BARC	access-site or access-related minor bleeding according to BARC	up to 7 days and 30-day
Secondary	Need for blood transfusion for access-site or access-related bleeding or vascular complications	Need for blood transfusion for access-site or access-related bleeding or vascular complications	up to 7 days
Secondary	Total number of blood transfusions because of access-site or access-related bleeding	Total number of blood transfusions because of access-site or access-related bleeding	up to 7 days
Secondary	Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis	Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis	24 hours
Secondary	Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment	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
Secondary	Length of postprocedural hospital stay	Length of postprocedural hospital stay	up to 7 days
Secondary	Time to hemostasis, defined as the time from VCD application to complete hemostasis	Time to hemostasis, defined as the time from VCD application to complete hemostasis	24 hours
Secondary	Need and number of additional unplanned VCDs	Need and number of additional unplanned VCDs	24 hours
Secondary	Percent diameter stenosis of vascular access vessel on post-procedural angiography	Percent diameter stenosis of vascular access vessel on post-procedural angiography	24 hours