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

February 3, 2026 updated by: Restore Medical Ltd

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Aalst, Belgium
        • Recruiting
        • Clinical Site
      • Antwerp, Belgium
        • Recruiting
        • Clinical Site
      • Genk, Belgium
        • Recruiting
        • Clinical Site
  • Georgia
      • Tbilisi, Georgia
        • Recruiting
        • Tbilisi Heart and Vascular Clinic
  • Germany
      • Lübeck, Germany
        • Recruiting
        • Clinical Site
  • Israel
      • Nahariya, Israel
        • Recruiting
        • Clinical Site
      • Petah Tikva, Israel
        • Recruiting
        • Clinical Site
      • Rehovot, Israel
        • Recruiting
        • Kaplan Medical Center
  • Lithuania
      • Klaipėda, Lithuania
        • Recruiting
        • Clinical Site
      • Vilnius, Lithuania
        • Recruiting
        • Vilnius University Hospital Santaros Klinikos
  • Poland
      • Krakow, Poland
        • Recruiting
        • Clinical Site
      • Lublin, Poland
        • Recruiting
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ContraBand implants
Percutaneous implantation of the ContraBand devices by right heart catheterization
Device: ContraBand implants
Percutaneous implantation of the ContraBand devices by right heart catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: Implantation procedure
Ability to successfully deliver devices to the Pulmonary Arteries
Implantation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restore Medical Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM-20-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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