Brief Title
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
Official Title
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
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 hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.
Detailed Description
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
Study Type
Interventional
Primary Outcome
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Secondary Outcome
Rate of access-site or access-related vascular injury
Condition
Aortic Valve Stenosis
Intervention
Manta
Study Arms / Comparison Groups
Manta
Description: plug-based vascular closure
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
516
Start Date
June 26, 2020
Completion Date
August 31, 2021
Primary Completion Date
June 28, 2021
Eligibility Criteria
Inclusion Criteria: 1. Patients with an indication for transfemoral TAVI as judged by the local heart team. 2. Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team. 3. The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations. Exclusion Criteria: 1. Vascular access site anatomy not suitable for percutaneous vascular closure. 2. Vascular access site complications prior to the TAVI procedure. 3. Known allergy or hypersensitivity to any VCD component. 4. Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia. 5. Absence of computed tomographic data of the access site before the procedure. 6. Systemic infection or a local infection at or near the access site. 7. Life expectancy of less than 6 months due to non-cardiac conditions. 8. Patient cannot adhere to or complete the investigational protocol for any reason. 9. Pregnant or nursing subjects. 10. Participation in any other interventional trial.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mohamed Abdel-Wahab, PD Dr., +49 341 865 1425, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04459208
Organization ID
HCRI2020-0191
Responsible Party
Sponsor
Study Sponsor
Leipzig Heart Institute GmbH
Study Sponsor
Mohamed Abdel-Wahab, PD Dr., Principal Investigator, Herzzentrum Leipzig GmbH
Verification Date
August 2020