Status:
RECRUITING
Comparison of a Single Versus Double Perclose Technique for TAVR
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Severe Aortic Stenosis
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis. It has been proven to ...
Detailed Description
SINGLE-CLOSURE (The utilization of Single versus double perclose devices for transfemoral aortIc valve replacement access site Closure) is an investigator-initiated, open-label, multicenter, randomize...
Eligibility Criteria
Inclusion
- Patients scheduled to undergo transfemoral TAVR were considered for inclusion in the trial if they met all inclusion and none of the exclusion criteria. Inclusion criteria were an indication for TAVR as judged by the local heart team; selection of the transfemoral access route and a commercially available transcatheter aortic valve; and willingness to comply with protocol specified follow-up evaluations.
Exclusion
- Principal exclusion criteria were a vascular access site anatomy not suitable for percutaneous vascular closure and the occurrence of vascular access site complications before the TAVR procedure. Additional exclusion criteria were a known allergy or hypersensitivity to any VCD component; unstable active bleeding or bleeding diathesis or significant unman ageable 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 \<6 months because of noncardiac conditions; patients who can-not adhere to or complete the investigational protocol for any reason; pregnant or nursing patients; and participation in any other interventional trial.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2026
Estimated Enrollment :
876 Patients enrolled
Trial Details
Trial ID
NCT06173115
Start Date
October 20 2023
End Date
June 28 2026
Last Update
October 14 2025
Active Locations (25)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
2
Fujian Provincial Hospital
Fuzhou, Fujian, China
3
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
4
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China