Comparing single and double closure techniques for aortic valve replacement

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

This study is testing whether a single or double closure technique after aortic valve replacement helps patients have fewer complications and better outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 876 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 25 sites (Bengbu, Anhui and 24 other locations)
• Trial ID: NCT06173115 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of single versus double Perclose techniques for vascular closure in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. It is a multicenter, randomized controlled trial where patients scheduled for TAVR will be randomly assigned to one of the two closure techniques. The study aims to assess the impact of these techniques on vascular complications and overall patient outcomes. Data will be managed by an independent coordinating center to ensure accuracy and reliability.

Who should consider this trial

Good fit: Ideal candidates are patients scheduled for transfemoral TAVR who meet the inclusion criteria set by the local heart team.

Not a fit: Patients with unsuitable vascular access site anatomy or those experiencing complications prior to the TAVR procedure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved vascular closure techniques, reducing complications and enhancing recovery for patients undergoing TAVR.

How similar studies have performed: While there have been studies on vascular closure techniques, this specific comparison of single versus double closure techniques in TAVR is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Bengbu, Anhui and 24 other locations

• 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)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi, Xinjiang, China (Recruiting)
• Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• Huzhou Central Hospital — Huzhou, Zhejiang, China (Recruiting)
• Ningbo Medical Center Li Huili Hospital — Ningbo, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
• Beijing Anzhen Hospital, Capital Medical University — Beijing, China (Recruiting)
• Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)

Study contacts

• Study coordinator: XianBao Liu, PhD

Conditions Severe Aortic Stenosis; transcatheter aortic valve replacement; vascular closure devices; randomized control trial