School of Medicine - LSU Health New Orleans



SHIELD II Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (Heartmate PHP)Main Inclusion:Undergoing elective or urgent high risk PCI procedure and is hemodynamically stableIndicated for a revascularization of at least one de novo or restenotic lesion in a native coronary vessel or bypass graftComplex CAD makes hemodynamic instability resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex CAD is defined as an ejection fraction of ≤35% AND at least one of the following:intervention of the last patent coronary conduit, ORintervention of an unprotected left main artery, ORintervention on patient presenting with triple vessel disease defined as at least one significant stenosis (at least 50% diameter stenosis on visual assessment) in all three major epicardial territoriesDCM Precision Medicine Study Main Inclusion:DCM (LVEF <50% and LV enlargement) Detectable causes of cardiomyopathy, except genetic, excluded beyond reasonable doubt (idiopathic)Non-Hispanic Ethnic OriginMain Exclusion:CAD causing ischemic cardiomyopathyPrimary valvular diseaseOther forms of cardiomyopathy such as Hypertrophic, Restrictive, etc.GALACTIC-HFA Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection FractionMajor Inclusion:History of chronic HF (requiring treatment >30 days)LVEF ≤ 35% currently, measured within 12 months of screeningNYHA II-IVCurrently hospitalized for Primary reason of HF, or one of the following:HF hospitalization within one yearUrgent visit to ED with primary reason of HFBNP ≥ 125 pg/mL, or BNP ≥ 375 pg/mL with A-fib/flutterMajor Exclusion:Acute coronary syndrome, stroke, TIA, or major cardiac surgery or intervention within 3 months prior to randomizationICD, pacemaker, or monitoring device implant within 30 days of randomizationSevere uncorrected valvular heart disease, hypertrophic or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart diseaseUntreated severe ventricular arrhythmiaChronic antiarrhythmic therapy, except amiodaroneEMPEROR-HFpEFA phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection FractionMajor Inclusion:History of chronic HF diagnosed for at least 3 months and currently NYHA II-IVLVEF ≥ 40% currently, measured within 12 months of screening with no prior measurement of LVEF<40% under stable conditions Evidence of structural heart disease (LA enlargement or LV hypertrophy) -OR- Documented HF hospitalization within 12 monthsOral diuretics stable for 1 week prior to randomization eGFR ≥ mL/min/1.73m2Major Exclusion:Acute coronary syndrome, stroke, TIA, or major cardiac surgery or intervention within 3 months prior to screeningHeart transplant recipient or listed for transplantICD within 3 monthsCRT Severe uncorrected valvular heart disease, hypertrophic or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart diseaseUntreated severe ventricular arrhythmiaTRANSFORM-HFTorsemide comparison with Furosemide FOR Management of Heart Failure (TRANSFORM-HF)Major Inclusion:Patient hospitalized for Heart FailureOutpatient plans for oral loop diuretic regimentMajor Exclusion:End-stage renal disease requiring renal replacement therapyHistory of heart transplant or listed for transplantImplanted LVAD or implant anticipated <3 monthsKnown hypersensitivity to furosemide, torsemide, or related agentsPARTNER 3-UPRA Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients who have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve ReplacementMajor Inclusion:Severe, calcific aortic stenosis defined as:AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg AND1) NYHA Functional Class ≥ 2 OR 2) exercise test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR 3) asymptomatic with LVEF <50%Patient has low risk of operative mortality and STS < 4Major Exclusion:Evidence of acute MI within 30 days of implantUnicuspid, bicuspid, or non-calcified aortic valveSevere aortic or mitral regurgitation (>3+)Complex CADLVEF < 30%HOCMeGFR < 30ml/minStroke or TIA within 3 months of implantGUIDE-HFHemodynamic-GUIDEd Management of Heart Failure (CardioMEMS indication expansion trial)Major Inclusion:HF diagnosis and treatment for HF > 90 days prior to screeningOn stable medical therapy for >30 daysHF hospitalization within 12 months of consent with elevated BNP (corrected to BMI) within 30 days defined as:Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).Major Exclusion:Intolerance to all ACE-I, ARB, ARNi, and beta-blockersACC/AHA Stage D refractory HFReceived or likely to receive advanced therapy in next 12 months (transplant, mechanical circulatory support, etc.)eGFR < 25 ml/min and non-responsive to diuretic therapy, or receiving chronic dialysisIntolerance of dual antiplatelet or anticoagulation therapy for 1 month post-implantationImplanted mechanical right heart valve(s) -OR- Unrepaired severe valvular diseaseImplanted with CRT, CRT-P, or CRT-D < 90 days ................
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