Last reviewed · How we verify
NCT05230745
ContraBand™: Safety & Feasibility Study (RM-20-01)
NA trial testing ContraBand implants in Heart Failure, Left Sided in 55 participants. Currently enrolling.
30 June 2029
Quick facts
| Lead sponsor | Restore Medical Ltd |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 28 September 2021 |
| Primary completion | 30 June 2029 |
| Estimated completion | 31 December 2032 |
| Sites | 12 locations across Georgia, Belgium, Israel, Germany, Poland, Lithuania |
Drugs / interventions tested
- ContraBand implants
Conditions studied
- Heart Failure, Left Sided — all drugs for Heart Failure, Left Sided →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05230745
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05230745 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Restore Medical Ltd
- Last refreshed: 5 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05230745.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing