Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart shunt device aims to boost energy in failing hearts

NCT ID NCT07555925

Disease control Sponsor: Heinrich-Heine University, Duesseldorf 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 called an interatrial shunt that is placed in the heart to relieve pressure. It involves 15 adults with advanced heart failure and reduced pumping ability. Researchers will use advanced heart scans and exercise tests to see if the device improves heart energy and function.

What this could mean

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

Active substance
Interatrial shunt device (Ventura IASD)
What this could lead to
If successful, this device could help the heart pump more efficiently and reduce symptoms like shortness of breath in people with heart failure.
What could go wrong
This is a very small early study with only 15 people, so results may not apply to everyone. The device is already approved for other uses, but its benefits for this specific heart failure type are not yet proven.

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 15 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

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

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: 1. Ischemic or non-ischemic cardiomyopathy with LVEF ≤ 40% 2. Patient is eligible and scheduled to receive the Ventura IASD as per the current IFU. 3. Symptoms: NYHA Class III 4. Stability: Chronic heart failure for ≥ 6 months on stable, and at least 3 months on guideline-directed medical therapy (GDMT) 5. Biomarkers: NTproBNP ≥ 1,200 pg/ml 6. Age 18 years or older 7. Subject has signed informed consent form and is willing and able to attend all follow-up visits and is physically capable of performing all tests. Exclusion Criteria: 1. Hemodynamics: Resting SBP \< 90 or \> 160 mmHg 2. Severe PH (PASP \>70 mmHg, PVR \> 4 Wood Units) 3. Anatomy/Structure: * intracardiac thrombus * Severe RV dysfunction (TAPSE \<12 mm or RVFAC ≤25%) * LVEDD \> 8 cm * Significant ASD or PFO 4. Valvular Disease: * Severe, untreated mitral stenosis or aortic stenosis or regurgitation * Mitral repair device \<3 months prior to enrollment 5. Recent Events: * ACS, PCI, Cardiac Surgery (\< 3 months prior to enrollment) * CAD requiring revascularization * Stroke, TIA, PE, Thrombosis (\< 6 months prior to enrollment) 6. Issues undergoing MRI: e.g non-compatible implant, claustrophobia, or physically not suitable for MRI 7. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint 8. Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits 9. Any non-cardiac condition with life expectancy \<1 years (e.g., cirrhosis, cancer not in remission, etc.) 10. Subject belongs to a vulnerable population

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure with reduced ejection fraction (hfref) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

systolic heart failure

As listed by the trial registrant

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

Heart failure with reduced ejection fraction (hfref)

How to take part

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

  1. The places running it

    1 site. 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

  • University Hospital Duesseldorf

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.