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Heart failure patients get a tiny implant that watches and helps the heart

NCT ID NCT07402239

Disease control Sponsor: United Innomed(Shanghai) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 small device implanted in the heart that measures pressure and creates a small opening to help blood flow. It is for people with chronic heart failure whose heart pumps weakly (ejection fraction 40% or less) and who still have symptoms despite standard treatments. The goal is to see if the device is safe and can reduce hospitalizations and improve daily function.

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 330 people

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

Started

Mar 2026

Expected to finish

Jun 2028

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.

Main Inclusion Criteria： * Age ≥ 18 years old * Clinically diagnosed with chronic heart failure * Receiving guideline directed medical and device therapy (GDMT) for heart failure * Left ventricular ejection fraction (LVEF) ≤ 40% assessed by echocardiography * New York Heart Association (NYHA) functional class II or III, with NYHA II criteria met simultaneously; for NYHA III, at least one of the following must be satisfied: 1. At least one hospitalization for heart failure within the past 12 months; 2. Elevated BNP or NT-proBNP within 3 months prior to enrollment (under normal sinus rhythm, NT-proBNP \> 900 pg/mL; under atrial fibrillation, NT-proBNP \> 1500 pg/mL; under normal sinus rhythm, BNP \> 300 pg/mL; under atrial fibrillation, BNP \> 500 pg/mL; BNP not applicable if the patient is using ARNI); * Able to perform 6-minute walk test (6MWT), with a distance between 100 meters and 450 meters Main Exclusion Criteria * Currently in an acute decompensation of chronic heart failure (hospitalization within 2 weeks prior to enrollment), refractory end-stage heart failure, or on the waiting list for heart transplantation (including LVAD indication); * BMI \> 40 kg/m² or \< 18.5 kg/m²; * Systolic blood pressure \<90 or ≥160 mmHg * Moderate or severe aortic or mitral stenosis, or planned during the trial intervention for severe regurgitation of the aortic, mitral, tricuspid, or pulmonary valves; * Coronary artery disease requiring revascularization; * Hypertrophic cardiomyopathy, active myocarditis, cardiac tamponade or large pericardial effusion, congenital heart disease, or other causes of heart failure * History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 3 months * Severe chronic lung disease requiring oxygen therapy or long-term corticosteroids; * Surgery involving atrial septal puncture within 3 months before enrollment (e.g., mitral repair, atrial fibrillation ablation, LAA closure); * Significant RV dysfunction - TAPSE \<12mm or RVFAC ≤25% * eGFR \<25 ml/min/1.73 m\^2

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Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure

How to take part

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

  1. The places running it

    15 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

  • Fuwai Central China Cardiovascular Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • Fuzhou University Affiliated Provincial Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, China

  • Guangdong Provincial People's Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Guizhou Provincial People's Hospital

    NOT_YET_RECRUITING

    Guiyang, Guizhou, China

  • Shanghai Chest Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • Sichuan Provincial People's Hospital

    NOT_YET_RECRUITING

    Chengdu, China

  • The First AFfiliated Hospital of MWU

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Ningbo University

    NOT_YET_RECRUITING

    Ningbo, Zhejiang, China

  • The First Hospital of Lanzhou University

    NOT_YET_RECRUITING

    Lanzhou, Gansu, China

  • The Second Affiliated Hospital Zhejiang University School of Medcine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Second Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • The Second Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • West China Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Xijing Hospital

    NOT_YET_RECRUITING

    Xi’an, Shanxi, China

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