NCT05230745

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

ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Restore Medical Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	ContraBand implants	Percutaneous implantation of the ContraBand devices by right heart catheterization

Timeline

• Start date: 2021-09-28
• Primary completion: 2029-06-30
• Completion: 2032-12-31
• First posted: 2022-02-09
• Last updated: 2026-02-05

Locations

12 sites across 6 countries: Belgium, Georgia, Germany, Israel, Lithuania, Poland