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

Recruiting now · Not applicable

Conditions studied: Heart Failure, Left Sided

In brief

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.

Key facts

Study ID
NCT05230745
Run by
Restore Medical Ltd
People needed
55
Starts
2021-09-28
Expected to finish
2032-12-31
Last updated by the study team
2026-02-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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