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Could a gentle zap protect older hearts from hidden lung threat after surgery?

NCT ID NCT07710001

Disease control Sponsor: Fujian Medical University Union Hospital 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether a device that delivers gentle electrical stimulation to the neck can prevent silent aspiration — when fluid or food enters the airway without causing coughing — in patients aged 60 and older after heart valve surgery. Researchers measure two substances in airway secretions as markers of aspiration. The goal is to see if this non-invasive intervention is safe and effective.

What this could mean

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

Active substance
Gentle Stim Electrical Stimulation Therapy Device (Model: JC-2071)
What this could lead to
If effective, this approach could reduce the risk of silent aspiration and related complications in elderly patients recovering from heart valve surgery.
What could go wrong
This is a small, early-stage study focused on biomarker outcomes, so results may not confirm clinical benefit. The device may not prevent aspiration in all patients.

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

117 people

The number who actually took part.

Started

Feb 2025

Finished

Jan 2026

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

60 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: * Simple valve surgery * Age ≥60 years old * NYHA cardiac function Grade II-III * ASA Grade II-III * No dysphagia screened by SSA before surgery Exclusion Criteria: * Vocal cord dysfunction, oropharyngeal malignancies, or neck surgery affecting swallowing function * Postoperative hemodynamic instability and active bleeding * COPD, asthma, chronic bronchitis, lung cancer or other respiratory diseases * Previous gastroesophageal reflux disease * Serious mental or neurological disease * Skin damage or electrode allergy at the stimulation site * Implanted cardiac pacemaker * Participation in other interventional studies

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As listed by the trial registrant

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

Elderly heart valve surgery Silent aspiration

Contacts and locations

Locations

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000, China

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