CompletedNo phase
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation
Key facts
- Who runs it
- Deutsches Herzzentrum Muenchen
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 450 people enrolled
- Started
- 1 Oct 2022
- Ended
- 18 Apr 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).
- Combination of two ProGlides or ProStyles (Abbott Vascular).
- Record updated
- 23 April 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Vascular access site complications prior to the TAVI procedure
- Known allergy or hypersensitivity to any component of the VCD
- Active bleeding or bleeding diathesis
- Systemic infection or local infection at or near the access site
- Limited long-term prognosis due to other comorbid conditions
- 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
- Vascular access site anatomy not suitable for percutaneous vascular closure device
- Absence of computed tomographic data of the access site before the procedure
- Patient cannot adhere to or complete the trial protocol for any reason
- Pregnancy
- Participation in any other interventional trial
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Combined suture- and plug-based VCD strategyTreatment being tested
1 ProGlide or ProStyle + 1 Angio-Seal
Treatment: Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo).
- Pure suture-based VCD strategyTreatment being tested
2 ProGlides or ProStyles
Treatment: Combination of two ProGlides or ProStyles (Abbott Vascular).
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation: The ACCESS-TAVI Randomized Trial
- Record updated
- 23 April 2024