Heart Failure, Left SidedNCT05230745
ContraBand™: Safety & Feasibility Study (RM-20-01)
A study testing ContraBand implants in people with Heart Failure, Left Sided, run by Restore Medical Ltd at 12 sites in 6 countries.
Trial summary
ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries. The effect is achieved by causing a local reduction in the internal diameters of the branch PAs, resulting in a lower distal systolic pulmonary artery pressure (PAP) as well as an attenuation in the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Left Sided
- What is being tested?
- ContraBand implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 28 Sep 2021to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
12 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 6 countries
Belgium3 sites, 3 recruiting
- Recruiting
Clinical Site
Aalst
- Recruiting
Clinical Site
Antwerp
- Recruiting
Clinical Site
Genk
Israel3 sites, 3 recruiting
- Recruiting
Clinical Site
Nahariya
- Recruiting
Clinical Site
Petah Tikva
- Recruiting
Kaplan Medical Center
Rehovot
Lithuania2 sites, 2 recruiting
- Recruiting
Clinical Site
Klaipėda
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
Poland2 sites, 2 recruiting
- Recruiting
Clinical Site
Krakow
- Recruiting
Clinical Site
Lublin
Georgia1 site, 1 recruiting
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi
About this study
Official title: ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure
ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries. The effect is achieved by causing a local reduction in the internal diameters of the branch PAs, resulting in a lower distal systolic pulmonary artery pressure (PAP) as well as an attenuation in the rise of the mean pulmonary capillary wedge pressure (PCWP) along with a higher pulmonary arterial compliance (PAC) distal to the constriction during exercise. Lower PCWP reflects the reduced left ventricular end diastolic pressure (LVEDP), contributing to enhanced ventricular filling and improved cardiac output. This hemodynamic change is anticipated to translate into enhanced physical capacity and a potentially more favorable prognosis for heart failure subjects. This study is an early feasibility, multi center, prospective, interventional, open-label, single-arm study.
- Conditions
- Heart Failure, Left Sided
- Being tested
- ContraBand implants
- Keywords
- pulmonary artery banding
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContraBand implantsDevice
Percutaneous implantation of the ContraBand devices by right heart catheterization
| Study group | Role | What they receive |
|---|---|---|
| ContraBand implants | Experimental | Percutaneous implantation of the ContraBand devices by right heart catheterization Receives: Device: ContraBand implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related or procedure-related major adverse events (MAEs)
MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; embolization and heart failure- related hospitalization.
Measured: 30 days
Secondary outcomes (1)
Procedural success
Ability to successfully deliver devices to the Pulmonary Arteries
Measured: Implantation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start28 Sep 2021
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, Left SidedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restore Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230745
- Sponsor's protocol ID
- RM-20-01
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure
- ClinicalTrials.gov ID
- NCT05230745
- Acronym / sponsor ID
- RM-20-01
- Conditions
- Heart Failure, Left Sided
- Keywords
- pulmonary artery banding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Restore Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries. The effect is achieved by causing a local reduction in the internal diameters of the branch PAs, resulting in a lower distal systolic pulmonary artery pressure (PAP) as well as an attenuation in the rise of the mean pulmonary capillary wedge pressure (PCWP) along with a higher pulmonary arterial compliance (PAC) distal to the constriction during exercise. Lower PCWP reflects the reduced left ventricular end diastolic pressure (LVEDP), contributing to enhanced ventricular filling and improved cardiac output. This hemodynamic change is anticipated to translate into enhanced physical capacity and a potentially more favorable prognosis for heart failure subjects. This study is an early feasibility, multi center, prospective, interventional, open-label, single-arm study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ContraBand implants | Experimental | Device: ContraBand implantsPercutaneous implantation of the ContraBand devices by right heart catheterization |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ContraBand implantsPercutaneous implantation of the ContraBand devices by right heart catheterization | Device | ContraBand implants |
Primary outcome
Device-related or procedure-related major adverse events (MAEs)
Time frame: 30 days
MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; embolization and heart failure- related hospitalization.
1 secondary outcome
Procedural success
Time frame: Implantation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ContraBand implants in people with Heart Failure, Left Sided, run by Restore Medical Ltd at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium, Israel, Lithuania, Poland, Georgia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Bellomo (+972 54 227 4831, stephen@restoremedical.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-related or procedure-related major adverse events (MAEs) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.