Related Experiment Video
Updated: Mar 27, 2026
Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
Published on: August 8, 2025
Single Versus Double Perclose Devices for TF-TAVR Access Closure: A Noninferiority Randomized Controlled Trial.
Jubo Jiang1, Lihan Wang1, Po Hu1
1Department of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China; State Key Laboratory of Transvascular Implantation Devices, Hangzhou, China; Heart Regeneration and Repair Key Laboratory of Zhejiang Province, Hangzhou, China.
This randomized trial compares single versus double Perclose ProGlide devices for transfemoral transcatheter aortic valve replacement (TF-TAVR) vascular closure. It aims to determine the safest and most effective approach for large-bore access site management.
Area of Science:
- Cardiovascular Interventions
- Vascular Surgery
- Clinical Trials
Background:
- The Perclose ProGlide device is standard for transfemoral transcatheter aortic valve replacement (TF-TAVR) arterial access closure.
- Previous studies comparing single vs. double device approaches show conflicting results, necessitating randomized trials.
Purpose of the Study:
- To evaluate the effectiveness and safety of single versus double Perclose ProGlide devices in TF-TAVR patients.
- To provide evidence-based guidance on optimal large-bore vascular closure strategies.
Main Methods:
- The Single-Closure trial is a multicenter, randomized controlled trial (NCT06173115).
- Patients aged over 65 with severe aortic stenosis undergoing TF-TAVR are randomized 1:1 to single or double Perclose closure.
- The primary endpoint is a composite of major and minor vascular complications at the access site.
Main Results:
- The primary endpoint is defined by Valve Academic Research Consortium 3 (VARC-3) criteria.
- Data collection focuses on access site-related complications during hospitalization for the index procedure.
Conclusions:
- This trial will compare clinical outcomes between single and double Perclose closure techniques.
- Results are expected to inform the optimal strategy for managing large-bore vascular access in TF-TAVR.
