ContraBand™: Safety & Feasibility Study (RM-20-01)
Condition(s) studied
Investigational drug(s) / intervention(s)
ContraBand implants: Percutaneous implantation of the ContraBand devices by right heart catheterization
Study 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
Primary outcome measure(s)
- Device-related or procedure-related major adverse events (MAEs) — 30 days
MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; embolization and heart failure- related hospitalization.
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Site | Aalst | Belgium | Recruiting |
| Clinical Site | Antwerp | Belgium | Recruiting |
| Clinical Site | Genk | Belgium | Recruiting |
| Tbilisi Heart and Vascular Clinic | Tbilisi | Georgia | Recruiting |
| Clinical Site | Lübeck | Germany | Recruiting |
| Clinical Site | Nahariya | Israel | Recruiting |
| Clinical Site | Petah Tikva | Israel | Recruiting |
| Kaplan Medical Center | Rehovot | Israel | Recruiting |
| Clinical Site | Klaipėda | Lithuania | Recruiting |
| Vilnius University Hospital Santaros Klinikos | Vilnius | Lithuania | Recruiting |
| Clinical Site | Krakow | Poland | Recruiting |
| Clinical Site | Lublin | Poland | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05230745 on ClinicalTrials.gov ↗ ← All trials in Poland