History of Changes for Study: NCT05503199

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

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Study Record Versions

Version	Submitted Date	Changes
1	August 15, 2022	None (earliest Version on record)
2	September 10, 2023	Recruitment Status, Study Status and Contacts/Locations
3	January 7, 2024	Study Status and Contacts/Locations
4	April 22, 2024	Recruitment Status, Study Status, Contacts/Locations and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	GE IDE No. T00122
Brief Title:	Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation (ACCESS-TAVI)
Official Title:	Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation: The ACCESS-TAVI Randomized Trial
Secondary IDs:

Study Status


Record Verification:	August 2022
Overall Status:	Not yet recruiting
Study Start:	September 1, 2022
Primary Completion:	September 1, 2023 [Anticipated]
Study Completion:	October 1, 2023 [Anticipated]

First Submitted:	August 2, 2022
First Submitted that Met QC Criteria:	August 15, 2022
First Posted:	August 16, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	August 15, 2022
Last Update Posted:	August 16, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Deutsches Herzzentrum Muenchen
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

Conditions


Conditions:	Aortic Valve Stenosis
Keywords:	Aortic Valve Stenosis Transcatheter Aortic Valve Implantation (TAVI) Vascular Closure Device

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	450 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Combined suture- and plug-based VCD strategy 1 ProGlide or ProStyle + 1 Angio-Seal	Device: Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo). Combined suture- and plug-based VCD strategy after TF-TAVI.
Experimental: Pure suture-based VCD strategy 2 ProGlides or ProStyles	Device: Combination of two ProGlides or ProStyles (Abbott Vascular). Pure suture-based VCD strategy after TF-TAVI.

Outcome Measures


Primary Outcome Measures:
1.	Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis. [ Time Frame: In-hospital, in average three days ] 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:
1.	Major or minor vascular and access-site-related complications after TF-TAVI. [ Time Frame: At 30-day follow-up ] Combination of major or minor vascular and access-site-related complications after TF-TAVI according to VARC-3 criteria.
2.	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. [ Time Frame: In-hospital (in average three days) and at 30-day follow-up ] Individual components of the primary endpoint according to VARC-3 criteria.
3.	Unplanned use of endovascular 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 ] Unplanned use of endovascular stent (e.g. covered stent) and/or vascular surgery or other endovascular interventions at the puncture site.
4.	Any bleedings. [ Time Frame: In-hospital (in average three days) and at 30-day follow-up ] Any type of bleedings according to VARC-3 criteria.
5.	Need for blood transfusions. [ Time Frame: In-hospital (in average three days) ] Need for blood transfusions for vascular access-site-related bleedings or vascular complications.
6.	Percent diameter stenosis of vascular access vessel. [ Time Frame: Intra-procedural ] Percent diameter stenosis of vascular access vessel on post-procedural angiography.
7.	All-cause mortality. [ Time Frame: In-hospital (in average three days) and at 30-day follow-up ] All-cause mortality according to VARC-3 criteria.
8.	Length of post-procedural hospital stay. [ Time Frame: In-hospital (in average three days) ] Length of post-procedural hospital stay (days).
9.	Time from VCD application to complete hemostasis. [ Time Frame: Intra-procedural ] Time from VCD application to complete hemostasis (seconds).

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Tobias Rheude, MD Telephone: +49 89 1218 2985 Email: rheude@dhm.mhn.de
Central Contact Backup:	Renate Bratke Telephone: + 49 89 1218 2660 Email: bratke.dhm@gmail.com
Study Officials:	Michael Joner, MD Principal Investigator Deutsches Herzzentrum München
Locations:	Germany, Bavaria
	Deutsches Herzzentrum München Munich, Bavaria, Germany, 80636

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: