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Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation (ACCESS-TAVI)

Primary Purpose

Aortic Valve Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).
Combination of two ProGlides or ProStyles (Abbott Vascular).
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation (TAVI), Vascular Closure Device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years and able to give consent
  • Patients with an indication for TF-TAVI as judged by the local multi-disciplinary heart team
  • Feasibility of transfemoral access route using commercially available transcatheter heart valves and delivery systems
  • Written informed consent

Exclusion Criteria:

  • Vascular access site anatomy not suitable for percutaneous vascular closure device
  • Vascular access site complications prior to the TAVI procedure
  • Known allergy or hypersensitivity to any component of the VCD
  • Active bleeding or bleeding diathesis
  • Absence of computed tomographic data of the access site before the procedure
  • Systemic infection or local infection at or near the access site
  • Limited long-term prognosis due to other comorbid conditions
  • Patient cannot adhere to or complete the trial protocol for any reason
  • Pregnancy
  • Participation in any other interventional trial
  • Patients with mechanical heart valves in mitral position
  • Patients with elevated international normalized ratio (INR) due to oral anticoagulation therapy requiring reversal of vitamin K antagonists prior to TAVI using prothrombin complex concentrate

Sites / Locations

  • Deutsches Herzzentrum MünchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Combined suture- and plug-based VCD strategy

Pure suture-based VCD strategy

Arm Description

1 ProGlide or ProStyle + 1 Angio-Seal

2 ProGlides or ProStyles

Outcomes

Primary Outcome Measures

Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis.
The primary outcome measure is a combination of major or minor vascular and access-site-related complications or need for additional interventional (e.g. covered stent implantation) or surgical procedures related to vascular hemostasis according to updated VARC-3 criteria.

Secondary Outcome Measures

Major or minor vascular and access-site-related complications after TF-TAVI.
Combination of major or minor vascular and access-site-related complications after TF-TAVI according to VARC-3 criteria.
Individual components of the primary endpoint, namely 1) major or minor vascular and access-site-related complications, 2) need for additional interventional or surgical procedures related to vascular hemostasis.
Individual components of the primary endpoint according to VARC-3 criteria.
Unplanned use of endovascular stent and/or vascular surgery or other endovascular interventions at the puncture site.
Unplanned use of endovascular stent (e.g. covered stent) and/or vascular surgery or other endovascular interventions at the puncture site.
Any bleedings.
Any type of bleedings according to VARC-3 criteria.
Need for blood transfusions.
Need for blood transfusions for vascular access-site-related bleedings or vascular complications.
Percent diameter stenosis of vascular access vessel.
Percent diameter stenosis of vascular access vessel on post-procedural angiography.
All-cause mortality.
All-cause mortality according to VARC-3 criteria.
Length of post-procedural hospital stay.
Length of post-procedural hospital stay (days).
Time from VCD application to complete hemostasis.
Time from VCD application to complete hemostasis (seconds).

Full Information

First Posted
August 2, 2022
Last Updated
September 10, 2023
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT05503199
Brief Title
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation
Acronym
ACCESS-TAVI
Official Title
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation: The ACCESS-TAVI Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.
Detailed Description
Detailed information is provided elsewhere.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation (TAVI), Vascular Closure Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined suture- and plug-based VCD strategy
Arm Type
Experimental
Arm Description
1 ProGlide or ProStyle + 1 Angio-Seal
Arm Title
Pure suture-based VCD strategy
Arm Type
Experimental
Arm Description
2 ProGlides or ProStyles
Intervention Type
Device
Intervention Name(s)
Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).
Intervention Description
Combined suture- and plug-based VCD strategy after TF-TAVI.
Intervention Type
Device
Intervention Name(s)
Combination of two ProGlides or ProStyles (Abbott Vascular).
Intervention Description
Pure suture-based VCD strategy after TF-TAVI.
Primary Outcome Measure Information:
Title
Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis.
Description
The primary outcome measure is a combination of major or minor vascular and access-site-related complications or need for additional interventional (e.g. covered stent implantation) or surgical procedures related to vascular hemostasis according to updated VARC-3 criteria.
Time Frame
In-hospital, in average three days
Secondary Outcome Measure Information:
Title
Major or minor vascular and access-site-related complications after TF-TAVI.
Description
Combination of major or minor vascular and access-site-related complications after TF-TAVI according to VARC-3 criteria.
Time Frame
At 30-day follow-up
Title
Individual components of the primary endpoint, namely 1) major or minor vascular and access-site-related complications, 2) need for additional interventional or surgical procedures related to vascular hemostasis.
Description
Individual components of the primary endpoint according to VARC-3 criteria.
Time Frame
In-hospital (in average three days) and at 30-day follow-up
Title
Unplanned use of endovascular stent and/or vascular surgery or other endovascular interventions at the puncture site.
Description
Unplanned use of endovascular stent (e.g. covered stent) and/or vascular surgery or other endovascular interventions at the puncture site.
Time Frame
In-hospital (in average three days) and at 30-day follow-up
Title
Any bleedings.
Description
Any type of bleedings according to VARC-3 criteria.
Time Frame
In-hospital (in average three days) and at 30-day follow-up
Title
Need for blood transfusions.
Description
Need for blood transfusions for vascular access-site-related bleedings or vascular complications.
Time Frame
In-hospital (in average three days)
Title
Percent diameter stenosis of vascular access vessel.
Description
Percent diameter stenosis of vascular access vessel on post-procedural angiography.
Time Frame
Intra-procedural
Title
All-cause mortality.
Description
All-cause mortality according to VARC-3 criteria.
Time Frame
In-hospital (in average three days) and at 30-day follow-up
Title
Length of post-procedural hospital stay.
Description
Length of post-procedural hospital stay (days).
Time Frame
In-hospital (in average three days)
Title
Time from VCD application to complete hemostasis.
Description
Time from VCD application to complete hemostasis (seconds).
Time Frame
Intra-procedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years and able to give consent Patients with an indication for TF-TAVI as judged by the local multi-disciplinary heart team Feasibility of transfemoral access route using commercially available transcatheter heart valves and delivery systems Written informed consent Exclusion Criteria: Vascular access site anatomy not suitable for percutaneous vascular closure device Vascular access site complications prior to the TAVI procedure Known allergy or hypersensitivity to any component of the VCD Active bleeding or bleeding diathesis Absence of computed tomographic data of the access site before the procedure Systemic infection or local infection at or near the access site Limited long-term prognosis due to other comorbid conditions Patient cannot adhere to or complete the trial protocol for any reason Pregnancy Participation in any other interventional trial Patients with mechanical heart valves in mitral position Patients with elevated international normalized ratio (INR) due to oral anticoagulation therapy requiring reversal of vitamin K antagonists prior to TAVI using prothrombin complex concentrate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Rheude, MD
Phone
+49 89 1218 2985
Email
rheude@dhm.mhn.de
First Name & Middle Initial & Last Name or Official Title & Degree
Renate Bratke
Phone
+ 49 89 1218 2660
Email
bratke.dhm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Joner, MD
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation

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