Endpoints. The primary endpoints are occurrence of all adverse events including but not limited to: · all MIs · cardiovascular hospitalization · serious ventricular arrhythmias sustained · VT (symptomatic or sustained VT [duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse] · VF · symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block · symptomatic heart failure (NYHA criteria + physical examination OR hospitalization due to heart failure) · renal failure · stroke · death Secondary Endpoints include the parameters: · change from baseline in LV dimensions (end-systolic volume index, end-diastolic volume index, left ventricular mass) · change from baseline in regional (infarct related) and global wall motion score · change from baseline in ejection fraction · cardiac rupture · NT-proBNP
Appears in 7 contracts
Samples: License and Commercialization Agreement (Bellerophon Therapeutics, Inc.), License and Commercialization Agreement (Bellerophon Therapeutics LLC), License and Commercialization Agreement (Bellerophon Therapeutics LLC)
