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Tiny lung artery implant aims to unburden failing hearts

NCT ID NCT05230745

Disease control Sponsor: Restore Medical Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests a device called ContraBand™, which is implanted in the lung arteries to reduce pressure on the heart. The goal is to see if it's safe and can improve exercise ability and symptoms in people with left-sided heart failure. About 55 adults with moderate to severe heart failure will take part.

What this could mean

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

Active substance
ContraBand implant (a device placed in the pulmonary arteries to reduce pressure on the heart)
What this could lead to
If it works, this device could offer a new way to manage heart failure symptoms and improve daily function without open surgery.
What could go wrong
This is a small, early feasibility study with no control group, so results may not apply broadly. Risks include device-related complications like stroke, heart attack, or need for emergency surgery.

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 55 people

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

Started

Sep 2021

Expected to finish

Dec 2032

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 to 85 years

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 is 18 - 85 years old * Chronic heart failure (\> 3 months) * Symptomatic left heart failure Stage C (NYHA Class III-IVa) or Class II with documented prior history of Class III-IVa heart failure. * LVEF 20 - 40% * Receiving optimally tolerated GDMT for at least 3 (three) months as referred in the 2021 ESC Guidelines for the optimal recommended pharmacological treatment indicated in patients with (NYHA class II-IV) heart failure with reduced ejection fraction (LVEF\< 40%). * If indicated according to the 2021 ESC Guidelines: Subject has an implantable cardioverter-defibrillator (ICD) for at least 1 month prior to screening. or subject is on cardiac resynchronization therapy (CRT)/pacemaker for at least 3 months prior to screening. * Able to complete six-minute walk test (6MWT) with distance between 100 meters and 400 meters. Main Exclusion Criteria: * Serum NT-proBNP \<300 pg/mL * Significant RV dysfunction with TAPSE \< 15 mm * Moderate to severe pulmonary hypertension (Pulmonary vascular resistance PVR ≥ 4.0 WU and PAPi \< 1.0 by RHC) * Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™ * Restrictive Cardiomyopathy or myocarditis * Any severe valve disease (Grade 3-4) and/or tricuspid regurgitation ≥ 2+ (in a scale of 5) * Hemodynamic instability: Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or mechanical hemodynamic support * Active bacterial endocarditis or previous history of SBE (Subacute bacterial endocarditis) * Any planned cardiac surgery or interventions within the next six (6) months * Need for coronary artery revascularization * Myocardial infarction or any percutaneous cardiovascular intervention within 1 month * Cardiovascular surgery, or carotid surgery within 3 months * Acute kidney insufficiency and/or end stage renal disease requiring chronic dialysis (eGFR \< 30) * Leukopenia (WBC \< 4000 cells/μL), anemia (Hgb \< 9 g/dL), thrombocytopenia (platelets \< 150,000 cells/μL) or any known blood clotting disorder * History of systemic or pulmonary thromboembolism within 12 months prior to Baseline visit; incidental small peripheral pulmonary emboli deemed clinically insignificant by the investigator are not considered exclusionary * Previous history of cardiogenic shock (unrelated to myocardial infraction) * Stroke, transient ischemic attack (TIA) or deep vein thrombosis (DVT) within 6 months of screening

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Conditions

The condition(s) this trial relates to.

heart failure left ventricular failure systolic heart failure

As listed by the trial registrant

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

Heart failure, left-sided

How to take part

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

  1. The places running it

    12 sites in 6 countries. 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

  • Clinical Site

    RECRUITING

    Aalst, Belgium

  • Clinical Site

    RECRUITING

    Antwerp, Belgium

  • Clinical Site

    RECRUITING

    Genk, Belgium

  • Clinical Site

    RECRUITING

    Lübeck, Germany

  • Clinical Site

    RECRUITING

    Nahariya, Israel

  • Clinical Site

    RECRUITING

    Petah Tikva, Israel

  • Clinical Site

    RECRUITING

    Klaipėda, Lithuania

  • Clinical Site

    RECRUITING

    Krakow, Poland

  • Clinical Site

    RECRUITING

    Lublin, Poland

  • Kaplan Medical Center

    RECRUITING

    Rehovot, Israel

  • Tbilisi Heart and Vascular Clinic

    RECRUITING

    Tbilisi, Georgia

  • Vilnius University Hospital Santaros Klinikos

    RECRUITING

    Vilnius, Lithuania

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