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NCT05230745

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

Recruiting now NA Last updated 5 February 2026
What this trial tests

NA trial testing ContraBand implants in Heart Failure, Left Sided in 55 participants. Currently enrolling.

Timeline
28 September 2021
Primary endpoint
30 June 2029
31 December 2032

Quick facts

Lead sponsorRestore Medical Ltd
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment55
Start date28 September 2021
Primary completion30 June 2029
Estimated completion31 December 2032
Sites12 locations across Georgia, Belgium, Israel, Germany, Poland, Lithuania

Drugs / interventions tested

Conditions studied

Sponsor

Restore Medical Ltd

Who can join

Adults 18 to 85, any sex, with Heart Failure, Left Sided. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Transcatheter Pulmonary Artery Banding for HFrEF: Initial Results: Exercise Hemodynamics From the Ongoing First-in-Human Trial.
    Bruckheimer E, Rackauskas G, Verheye S, Prihadi E, et al · · 2024 · cited 6× · PMID 38680953 · DOI 10.1016/j.jacbts.2024.02.008

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