CLINICAL TRIALS
CLINICAL TRIALS
ISCHEMIC HEART DISEASE
Trial : AGENT IDE PI : Mustafa Ahmed , MD Brief Synopsis : A Prospective Randomized ( 2:1 ) Multicenter Trial to Assess the Safety and Effectiveness of the Agent™ Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects with In-Stent Restenosis ( ISR )
CARDIAC RHYTHM DISORDERS
Trial : Champion AF PI : Tom McElderry , MD Brief Synopsis : To Determine if Left Atrial Appendage Closure with the WATCHMAN FLX Device is a Reasonable Alternative to Non-Vitamin K Oral Anticoagulants ( NOACs ) in Patients with Non- Valvular Atrial Fibrillation
Trial : ECP PI : Mustafa Ahmed , MD Brief Synopsis : Use of the Impella ECPTM in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention
Trial : AIM Higher PI : Ruchit Shah , MD Brief Synopsis : Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction
Trial : SOS AMI PI : Hussein Abu Daya , MD Brief Synopsis : Selatogrel Outcome Study in Suspected Acute Myocardial Infarction ( SOS-AMI )
HEART FAILURE
Trial : Respira PI : Jose Tallaj , MD Brief Synopsis : A Phase 2 , Open-Label , Dose Escalation Study to Evaluate the Safety and Efficacy of RT234 on Exercise Parameters Assessed by Cardiopulmonary Exercise Testing ( CPET ) in Subjects with Pulmonary Arterial Hypertension ( PAH )
Trial : REBIRTH PI : Gretchen Wells , MD Brief Synopsis : Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy ( REBIRTH ) for Peripartum Cardiomyopathy
Trial : AF FLOW PI : William Maddox , MD Brief Synopsis : A Post-Market , Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using the Ablamap ® Electrographic FLOW ( EGF ) Mapping System to Guide Ablation Therapy in Patients with Atrial Fibrillation
VALVE DISEASE
Trial : Expand II PI : Mustafa Ahmed , MD Brief Synopsis : Evolut™ EXPAND TAVR II Pivotal Trial
Trial : PARADIGM PI : Mustafa Ahmed , MD Brief Synopsis : PARAvalvular Leak Closure with the Amplatzer Valvular Plug OccluDer for Interventional Transcatheter Closure for PVL with Surgical BioloGical and Mechanical Heart Valve ( PARADIGM )
Trial : Anthem HFrEF PI : Jose Tallaj , MD Brief Synopsis : Autonomic Regulation Therapy Using the VITARIA System to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction
Trial : Restore IDE PI : James Davies , MD Brief Synopsis : A Prospective , Multi-Center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair with The HARPOON™ System ( RESTORE )
30 UAB Cardiovascular Institute Annual Report