The Utilization of Single Versus Double Perclose Devices for Transfemoral Aortic Valve Replacement Access Site Closure: A Prospective, Multicenter, Randomized Controlled Trial

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
Fuwai Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Xiangya Hospital of Central South University
RECRUITING
Changshacun
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Fujian Provincial Hospital
RECRUITING
Fuzhou
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Huzhou Central Hospital
RECRUITING
Huzhou
Qilu Hospital of Shandong University
RECRUITING
Jinan
The First Hospital of Lanzhou University
RECRUITING
Lanzhou
Ningbo Medical Center Li Huili Hospital
RECRUITING
Ningbo
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Qingdao Municipal Hospital
RECRUITING
Qingdao
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
General Hospital of Northern Theater Command, PLA
RECRUITING
Shenyang
People's Hospital of Xinjiang Uygur Autonomous Region
RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
Yulin First People's Hospital
RECRUITING
Yulin
The Affiliated Hospital of Guangdong Medical University
RECRUITING
Zhanjiang
Fuwai Central China Cardiovascular Hospital
RECRUITING
Zhengzhou
Henan Provincial Chest Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
XianBao Liu, PhD
liuxb@zju.edu.cn
13857173887
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2026-06-28
Participants
Target number of participants: 876
Treatments
Active_comparator: Double Perclose device
Double Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures
Experimental: Single Perclose device
Single Perclose device ( Perclose Proglide system, Abbott Vascular) was used for large bore arteriotomy site closure during TF-TAVR procedures
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov