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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Percutaneous implantation of the ContraBand devices by right heart catheterization
Clinical Site
Aalst, Belgium
RECRUITINGClinical Site
Antwerp, Belgium
RECRUITINGClinical Site
Genk, Belgium
RECRUITINGTbilisi Heart and Vascular Clinic
Tbilisi, Georgia
RECRUITINGClinical Site
Lübeck, Germany
RECRUITINGClinical Site
Nahariya, Israel
RECRUITINGClinical Site
Petah Tikva, Israel
RECRUITINGKaplan Medical Center
Rehovot, Israel
RECRUITINGClinical Site
Klaipėda, Lithuania
RECRUITINGVilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
RECRUITING...and 2 more locations
Device-related or procedure-related major adverse events (MAEs)
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.
Time frame: 30 days
Procedural success
Ability to successfully deliver devices to the Pulmonary Arteries
Time frame: Implantation procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.