New bendable tube could make heart valve surgery safer
NCT ID NCT07320274
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a new device called the ArcFlex Sheath, a bendable tube used during TAVR surgery to replace a faulty aortic valve. The goal is to see if it helps doctors position the new valve more easily and safely compared to a standard sheath. About 180 people who need TAVR surgery will take part. The study will measure how often the surgery is successful and track survival rates at 30 days and one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ArcFlex Sheath (a bendable tube used during heart valve replacement surgery)
- What this could lead to
- If it works, this could make TAVR heart valve surgery safer and more successful by helping doctors position the new valve more easily.
- What could go wrong
- This is an early-stage device trial with only 180 people, so results may not apply to everyone. There are always risks with any new surgical tool, such as damage to blood vessels.
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
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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
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Judged by a professional cardiologist to require TAVR surgery * NYHA ≥ II grade * Evaluated by the cardiac team, the peripheral vascular approach is suitable for performing the surgery via the femoral route * Expected lifespan is greater than 1 year (5) Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups. Exclusion Criteria: * Presence of other valvular diseases requiring concurrent intervention. * Anatomical characteristics unsuitable for transcatheter valve implantation. * Severe mitral stenosis due to organic causes requiring surgical valve replacement or repair. * Hypertrophic obstructive cardiomyopathy (unexplained myocardial hypertrophy \>1.5 cm). * Acute myocardial infarction within the past 30 days. * Intracardiac mass, thrombus, or vegetation indicated by echocardiography. * Active infective endocarditis or any other active infection. * Intolerance to tolerate anticoagulant or antiplatelet therapy. * Coagulopathy or refusal to receive blood transfusion therapy. * Known allergy to device materials or contrast agents. * Acute peptic ulcer or gastrointestinal bleeding within the past 3 months. * Stroke or transient ischemic attack (TIA) within the past 3 months. * Requirement for emergency surgical treatment for any reason. * Expected life expectancy of less than 12 months due to non-cardiac causes. * Severe disabling dementia or inability to perform activities of daily living. * Participation in other clinical trials of drugs or medical devices prior to enrollment and not yet reached the primary endpoint of that study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
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Other studies related to the condition(s) this trial covers.