RecruitingNot ApplicableNCT05230745

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

ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure

Sponsor

Restore Medical Ltd

Enrollment

55 participants

Start Date

Sep 28, 2021

Study Type

INTERVENTIONAL

Conditions

Heart Failure, Left Sided

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This safety study is evaluating a new implantable device called ContraBand, which is designed to help the heart pump more effectively in patients with advanced heart failure. The device is implanted to reduce the strain on the weakened left ventricle. **You may be eligible if...** - You are between 18 and 85 years old - You have had chronic heart failure for more than 3 months - Your heart failure symptoms are severe (NYHA Class III–IVa, or Class II with a documented history of worse symptoms) - Your heart's pumping ability (ejection fraction) is between 20% and 40% - You have been on optimal medical therapy for at least 3 months **You may NOT be eligible if...** - You are on the transplant waiting list - You have recently had a cardiac resynchronization device implanted - You are on home oxygen therapy - You have severe lung disease - You cannot walk independently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContraBand implants

Percutaneous implantation of the ContraBand devices by right heart catheterization

Locations(12)

Clinical Site

Aalst, Belgium

Clinical Site

Antwerp, Belgium

Clinical Site

Genk, Belgium

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Clinical Site

Lübeck, Germany

Clinical Site

Nahariya, Israel

Clinical Site

Petah Tikva, Israel

Kaplan Medical Center

Rehovot, Israel

Clinical Site

Klaipėda, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Clinical Site

Krakow, Poland

Clinical Site

Lublin, Poland

View Full Details on ClinicalTrials.gov

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NCT05230745