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One stitch or two? major trial tests simpler closure for heart valve procedure

NCT ID NCT06173115

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using one stitch device (Perclose) is as safe and effective as using two to close the leg artery after a minimally invasive heart valve replacement (TAVR) in people with severe aortic stenosis. About 876 participants will be randomly assigned to one of the two methods. The goal is to see if using a single device can reduce costs and procedure time without increasing complications like bleeding or artery damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 876 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe aortic stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Anzhen Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • Fujian Provincial Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Fuwai Central China Cardiovascular Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, China

  • General Hospital of Northern Theater Command, PLA

    RECRUITING

    Shenyang, Liaoning, China

  • Henan Provincial Chest Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Huzhou Central Hospital

    RECRUITING

    Huzhou, Zhejiang, China

  • Nanfang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Ningbo Medical Center Li Huili Hospital

    RECRUITING

    Ningbo, Zhejiang, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    RECRUITING

    Ürümqi, Xinjiang, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, China

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, Shandong, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • The Affiliated Hospital of Guangdong Medical University

    RECRUITING

    Zhanjiang, Guangdong, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, China

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, Anhui, China

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, China

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Hospital of Lanzhou University

    RECRUITING

    Lanzhou, Gansu, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changshacun, Henan, China

  • Yulin First People's Hospital

    RECRUITING

    Yulin, Guangxi, China

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