Clinical trial NCT05503199: Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation
Official title: Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation: The ACCESS-TAVI Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
Transcatheter Aortic Valve Implantation (TAVI)
Vascular Closure Device
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Major or minor vascular and access-site-related complications or need for additional interventional or surgical procedures related to vascular hemostasis.
timeFrame: In-hospital, in average three days
Secondary outcomes:
measure: Major or minor vascular and access-site-related complications after TF-TAVI.
timeFrame: At 30-day follow-up
measure: 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.
timeFrame: In-hospital (in average three days) and at 30-day follow-up
measure: Unplanned use of endovascular stent and/or vascular surgery or other endovascular interventions at the puncture site.
timeFrame: In-hospital (in average three days) and at 30-day follow-up
measure: Any bleedings.
timeFrame: In-hospital (in average three days) and at 30-day follow-up
measure: Need for blood transfusions.
timeFrame: In-hospital (in average three days)
measure: Percent diameter stenosis of vascular access vessel.
timeFrame: Intra-procedural
measure: All-cause mortality.
timeFrame: In-hospital (in average three days) and at 30-day follow-up
measure: Length of post-procedural hospital stay.
timeFrame: In-hospital (in average three days)
measure: Time from VCD application to complete hemostasis.
timeFrame: Intra-procedural
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum München
name: Michael Joner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum München
name: Tobias Rheude, MD
role: PRINCIPAL_INVESTIGATOR
References: