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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.
Background:
The Double Perclose ProGlide (Abbott Vascular Devices) is widely adopted device for closing the main arterial access in transfemoral transcatheter aortic valve replacement (TF-TAVR). Previous observational studies have compared the single device vs double device approach, yielding controversial results and highlighting a gap in clinical randomized controlled trials.
Objectives:
The authors sought to evaluate the effectiveness and safety of single vs double Perclose ProGlide devices in patients undergoing TF-TAVR.
Methods:
The Single-Closure trial was been launched in 2024 (NCT06173115). It is an investigator-initiated, open-label, multicenter, noninferior, randomized controlled trial designed to compare the clinical outcomes of single vs double Perclose closure devices. Eligible participants include patients over 65 years of age with severe aortic stenosis and indicated for TF-TAVR. These patients are randomly assigned in a 1:1 ratio to either the single Perclose closure group or the double Perclose closure group.
Results:
The primary endpoint of the trial is the composite of access site or access-related major and minor vascular complications during hospitalization for the index procedure, as defined by the Valve Academic Research Consortium 3 criteria.
Conclusions:
This trial aims to compare the clinical outcomes of single vs double Perclose closure. Results of this trial may provide valuable insights into the optimal strategy for large-bore vascular closure.
