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New balloon shows promise in heart valve procedure

NCT ID NCT07304427

Disease control Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a balloon catheter called Alwide Plus, used to widen the aortic valve before replacing it in people with severe aortic stenosis. 75 patients took part across multiple hospitals in China. The results showed the balloon was safe and effective for this pre-dilation step, helping the new valve be placed correctly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Alwide Plus balloon catheter
What this could lead to
If successful, this could confirm that the Alwide Plus balloon is a safe and effective tool for preparing the aortic valve before replacement, improving outcomes for patients with severe aortic stenosis.
What could go wrong
This is a small, single-arm study with no comparison group, so results may not apply to all patients. The balloon is only one part of a complex procedure, and success depends on many factors.

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.

Participants

75 people

The number who actually took part.

Started

Jan 2025

Finished

Nov 2025

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.

Who is studied

Patients suffering severe aortic stenosis and requiring pre-dilation during TAVR

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: * Age≥18 years old; * Severe aortic stenosis verified by echocardiogram: mean transvalvular gradient≥40mmHg (1mmHg=0.133kPa), or peak aortic jet velocity≥4m/s, or aortic valve area (AVA) ≤ 1.0cm2 (or AVA index≤ 0.6cm2/m2); * Patients, who can understand the clinical investigation purpose, voluntary agree and sign the informed consent form, and willing to comply with relevant trial assessments and clinical follow up Exclusion Criteria: * Aortic valve anatomy or lesion unsuitable or not necessary for balloon pre-dilation during the TAVR procedure * TAVR procedure in trans-apical access * Pre-implanted mechanical or bioprosthetic valve at the aortic valve position * Acute myocardial infarction (MI) occurred in the last 30 days before the treatment； * LVOT obstruction; * Serious left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% * Echocardiographic evidence of intracardiac mass, thrombus or neoplasm； * Unable to receive anticoagulation or antiplatelet therapy； * Allergy to nitinol or sensitive contrast media； * Active bacterial endocarditis or other active infection may affect the procedure； * Aortic valve anatomy , lesion, or other situation unsuitable for the prosthesis valve implantation as assessed by the investigator team； * Life expectancy \> 12 months； * vulnerable individuals who are unable to give informed consent/ unable to fully understand all aspects of the investigation or Severe incapacitating Alzheimer's disease； * Patients who participated in other clinic trials of drugs or medical device before being enrolled for which the primary endpoint follow up duration has not been reached； * Investigators determined that patients have poor compliance and can't complete the study as required

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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 Transcatheter aortic valve replacemen

Contacts and locations

Locations

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, China

  • Guangdong Provincial People's Hospital

    Guangzhou, China

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, China

  • Yan'an Hospital of Kunming City

    Kunming, Yunnan, China

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