Clinical Research Directory

Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction

This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). This study consists of a screening period (to occur at least 3 days after MI diagnosis), a 6-month double-blind period, and a 6-month extension period with the End of Study (EOS) Visit at Day 360/Month 12. Two dosages of CDR132L will be tested against placebo on their effects on patients, who just had a heart attack in addition to standard care. The aim of the study is to show that CDR132L is safe and effective to improve heart failure in such patients.

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

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.