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Brain catcher: new device may prevent stroke during heart procedure

NCT ID NCT07648693

Disease control Sponsor: Resonova (Shanghai) Medtech Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new device called CHORDS that catches loose debris during a heart valve replacement procedure (TAVR). The debris can travel to the brain and cause a stroke. The trial will compare CHORDS to an existing device in 240 people with severe aortic stenosis. Participants will be followed for 90 days to see if the new device reduces brain injury and other complications.

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 240 people

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

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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: * Male or non-pregnant female, ≥18 years * Patients with symptomatic severe aortic stenosis who are scheduled to undergo TAVR with commercialized transcatheter aortic valve system. * Compatible left common carotid artery (6.5-10 mm) and brachiocephalic artery (9-15mm) diameters without significant stenosis (\> 70%) * Patients who are able to understand the study objectives, voluntarily participate, sign the informed consent form, and are willing to undergo required examinations and clinical follow-up. Exclusion Criteria: General * Contraindications to MRI, or planned implantation of an MRI-incompatible device at the index procedure, or planned implantation of an MRI-incompatible pacemaker or defibrillator within 30 days post-procedure. * Acute myocardial infarction ≤ 30 days before the intended treatment * Pure aortic regurgitation * Pre-existing prosthetic aortic valve * Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation * Contraindication to antiplatelet and/or anticoagulant therapy, nitinol , or contrast media, or refusal to receive blood transfusions * Vulnerable populations, including those unable to adequately understand the trial, those potentially subject to undue influence or coercion, those unable to complete the informed consent process, and those with severe disabling dementia or cognitive impairment Anatomic * Vasculature (ie, right radial/brachial artery, carotid artery) precluding the device access * Patients whose brachiocephalic or left carotid artery reveals significant stenosis（\>70%）, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis stroke disorder

As listed by the trial registrant

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

Cerebral vascular accident (CVA)/stroke Transcatheter aortic valve replacement (TAVR)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, China

  • Beijing Anzhen Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, China

    Contact Email: •••••@•••••

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Qingdao University Affiliated Hospital

    RECRUITING

    Qingdao, Shandong, China

  • Southern Medical University Nanfang Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, Anhui, China

  • The First Affiliated Hospital of Fujian Medical University

    NOT_YET_RECRUITING

    Fuzhou, Fujian, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, China

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