ContraBand™: Safety & Feasibility Study (RM-20-01)

NCT05230745 | Recruiting DMC

• 1 other identifier: RM-20-01
• Study Type: interventional
• Target: 55
• Locations: 6 countries
• Sites: 12

Brief 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 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

Keywords

pulmonary artery banding

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (1)

• Procedural success

  Implantation procedure

Study Arms (1)

ContraBand implants

EXPERIMENTAL

Percutaneous implantation of the ContraBand devices by right heart catheterization

Device: ContraBand implants

Interventions

ContraBand implants DEVICE

Percutaneous implantation of the ContraBand devices by right heart catheterization

ContraBand implants

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Previous history of cardiogenic shock (unrelated to myocardial infraction)

Sponsors & Collaborators

• Restore Medical Ltd: lead

Study Sites (12)

Clinical Site

Aalst, Belgium

RECRUITING

Clinical Site

Antwerp, Belgium

RECRUITING

Clinical Site

Genk, Belgium

RECRUITING

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

RECRUITING

Clinical Site

Lübeck, Germany

RECRUITING

Clinical Site

Nahariya, Israel

RECRUITING

Clinical Site

Petah Tikva, Israel

RECRUITING

Kaplan Medical Center

Rehovot, Israel

RECRUITING

Clinical Site

Klaipėda, Lithuania

RECRUITING

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

RECRUITING

Clinical Site

Krakow, Poland

RECRUITING

Clinical Site

Lublin, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Stephen Bellomo

CONTACT

+972 54 227 4831; stephen@restoremedical.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 9, 2022
• Study Start: September 28, 2021
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

LI (2); IL (3); GE (1); PL (2); DE (1); BE (3)