Comparison of a Single Versus Double Perclose Technique for TAVR

Recruiting now · Not applicable

Conditions studied: Severe Aortic Stenosis

In brief

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 be a safe and effective option for patients who are at low, intermediate, and prohibitive risk for surgical valve replacement. One of the critical components of procedural success in a transfemoral approach is access site management, as vascular complications strongly correlate with adverse outcomes. When major vascular complications occur, there are higher rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as a significantly higher rate of 30-day and 1-year mortality. In recent years, a "preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site. This allows for arterial closure after dilation to sizing up to larger bore access sheaths that accommodate valve delivery systems. The sutures are subsequently harvested and tightened to close the large bore arteriotomy site at the end of the case. It has been demonstrated that the use of two Perclose devices, or double Perclose closure, is an effective closure technique with a low rate of vascular complications. A large number of TAVR centers have adopted this method for large-bore vascular closure. In the past, there have been few investigations comparing the utilization of a single Perclose device compared to a double Perclose technique. There are numerous theoretical advantages to the use of a single device, which include decreased procedural cost and procedural time. The investigation aimed to determine if there are clinical benefits as well using the single Perclose approach.

Key facts

Study ID: NCT06173115
Run by: Second Affiliated Hospital, Zhejiang University, School of Medicine
People needed: 876
Starts: 2023-10-20
Expected to finish: 2026-06-28
Last updated by the study team: 2025-10-14

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (enrolling)
Fujian Provincial Hospital — Fuzhou, Fujian, China (enrolling)
The First Hospital of Lanzhou University — Lanzhou, Gansu, China (enrolling)
Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)
The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
The Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (enrolling)
Yulin First People's Hospital — Yulin, Guangxi, China (enrolling)
Xiangya Hospital of Central South University — Changshacun, Henan, China (enrolling)
Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (enrolling)
Henan Provincial Chest Hospital — Zhengzhou, Henan, China (enrolling)
The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
General Hospital of Northern Theater Command, PLA — Shenyang, Liaoning, China (enrolling)
Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
Qingdao Municipal Hospital — Qingdao, Shandong, China (enrolling)
The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)
The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (enrolling)
Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)
People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi, Xinjiang, China (enrolling)
Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
Huzhou Central Hospital — Huzhou, Zhejiang, China (enrolling)
Ningbo Medical Center Li Huili Hospital — Ningbo, Zhejiang, China (enrolling)
The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (enrolling)
The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (enrolling)
Beijing Anzhen Hospital, Capital Medical University — Beijing, China (enrolling)
Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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