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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Manta; Device: ProGlide

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany
    • Herzzentrum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manta; plug-based vascular closure	Device: Manta; plug-based vascular closure
Active Comparator: ProGlide; suture-based vascular closure	Device: ProGlide; suture-based vascular closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Leipzig Heart Institute GmbH
• Investigators: Principal Investigator: Mohamed Abdel-Wahab, PD Dr., Herzzentrum Leipzig GmbH

Publications and helpful links

General Publications

• Abdel-Wahab M, Hartung P, Dumpies O, Obradovic D, Wilde J, Majunke N, Boekstegers P, Müller 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2020
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): August 4, 2021

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Transcatheter aortic valve implantation; Vascular access site closure; Vascular closure device; Vascular access-site injury
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2020-0191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No