Prevention Studies
DAL-GENE-2: This study evaluates the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal heart attacks in patients with a documented recent acute coronary syndrome (ACS) and the AA genotype at variant rs1967309 in the ADCY9 gene.
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Heart Failure Studies
CORCINCH-HF: This clinical study evaluates the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
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EMPOWER: This clinical trial assesses the safety and efficacy of the Carillon Mitral Contour System in treating heart failure patients who have early-stage functional mitral regurgitation (FMR).
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PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III: This study evaluates the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III heart failure patients (PROACTIVE-HF-2 Trial).
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Device Studies
ACURATE IDE: This study evaluates the safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in people with severe native aortic stenosis.
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ALLIANCE: This study establishes the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in people with symptomatic, severe, calcific aortic stenosis (AS).
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AMPLATZER PFO: This study confirms the safety and effectiveness of the AMPLATZER PFO Occluder in the post-approval setting.
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AVENTUS: This study evaluates the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in people with acute pulmonary embolism.
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CATALYST: This clinical trial evaluates the safety and effectiveness of the Amulet device compared to novel oral anticoagulant (NOAC) therapy in patients with non-valvular atrial fibrillation at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.
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COMPLETE TAVR: Among patients who have undergone a successful elective transfemoral TAVR, this study will determine whether a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of cardiovascular death, new heart attack, ischemia driven revascularization or hospitalization.
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CONFORM: This study evaluates if the CLAAS® device is similar in safety and efficacy to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation.
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EDWARDS PASCAL CLASP IID/IIF Pivotal Clinical Trial: This study evaluates the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation.
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ENCIRCLE: This study will establish the safety and effectiveness of the SAPIEN M3 System in people with symptomatic, at least 3+ mitral regurgitation (MR), for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.
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PEERLESS: This study compares the FlowTriever system to catheter-directed thrombolysis (CDT) for acute intermediate-high-risk pulmonary embolism (PE) and includes a non-randomized group made up of 150 subjects who are not able to receive thrombolytics.
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PROGRESS: This study’s objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis.
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SPYRAL AFFIRM: This study seeks to determine the long-term safety, efficacy and durability of the Symplicity Spyral system in subjects treated with renal denervation. Watch a Simplicity Spyral Procedure Animation.
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