Status:
COMPLETED
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
Lead Sponsor:
Helios Health Institute GmbH
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 hypothes...
Detailed Description
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
Eligibility Criteria
Inclusion
- Patients with an indication for transfemoral TAVI as judged by the local heart team.
- Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
- The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.
Exclusion
- Vascular access site anatomy not suitable for percutaneous vascular closure.
- Vascular access site complications prior to the TAVI procedure.
- Known allergy or hypersensitivity to any VCD component.
- Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
- Absence of computed tomographic data of the access site before the procedure.
- Systemic infection or a local infection at or near the access site.
- Life expectancy of less than 6 months due to non-cardiac conditions.
- Patient cannot adhere to or complete the investigational protocol for any reason.
- Pregnant or nursing subjects.
- Participation in any other interventional trial.
Key Trial Info
Start Date :
June 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2021
Estimated Enrollment :
516 Patients enrolled
Trial Details
Trial ID
NCT04459208
Start Date
June 26 2020
End Date
August 4 2021
Last Update
September 29 2021
Active Locations (1)
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1
Herzzentrum Leipzig
Leipzig, Germany