Condition: Severe Aortic Stenosis · Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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 utiliz…
This description comes directly from the study's public registry record.
XianBao Liu, PhD · 13857173887 · liuxb@zju.edu.cn
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| The First Affiliated Hospital of Bengbu Medical College | Bengbu, Anhui, China | Recruiting |
| Fujian Provincial Hospital | Fuzhou, Fujian, China | Recruiting |
| The First Hospital of Lanzhou University | Lanzhou, Gansu, China | Recruiting |
| Nanfang Hospital, Southern Medical University | Guangzhou, Guangdong, China | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong, China | Recruiting |
| The Affiliated Hospital of Guangdong Medical University | Zhanjiang, Guangdong, China | Recruiting |
| Yulin First People's Hospital | Yulin, Guangxi, China | Recruiting |
| Xiangya Hospital of Central South University | Changshacun, Henan, China | Recruiting |
| Fuwai Central China Cardiovascular Hospital | Zhengzhou, Henan, China | Recruiting |
| Henan Provincial Chest Hospital | Zhengzhou, Henan, China | Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha, Hunan, China | Recruiting |
| General Hospital of Northern Theater Command, PLA | Shenyang, Liaoning, China | Recruiting |
+ 13 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06173115