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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Manta; Device: ProGlide

• Registration Number: NCT04459208
• Lead Sponsor: Helios Health Institute GmbH

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.

Study Timeline

• Study Start: 2020-06-26
• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Primary Completion: 2021-07-07
• Study Completion: 2021-08-04
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manta	Manta	plug-based vascular closure
ProGlide	ProGlide	suture-based vascular closure

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	30 days	Rate of 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	Rate of major access-site or access-related vascular injury
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
all-cause death	up to 7 days and 30-day	all-cause death
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
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
Percent diameter stenosis of vascular access vessel on post-procedural angiography	24 hours	Percent diameter stenosis of vascular access vessel on post-procedural angiography
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
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 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
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
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
Length of postprocedural hospital stay	up to 7 days	Length of postprocedural hospital stay
Need and number of additional unplanned VCDs	24 hours	Need and number of additional unplanned VCDs
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

Trial Locations

Locations (1)

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany