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Clinical Studies
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A Prospective Research Investigation of Ischemia using SandboxAQ Magnetocardiography device (PRISM)
Rochester, Minn.
The purpose of this is to characterize the relationship between pre-procedural MCG-based, and the peri-procedural angiography-based measures. The quantitative angiographic measures may include the location(s) and extent of stenosis, TIMI flow grade, OMI vs. NOMI determination.
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Impact of General Anesthesia vs. Moderate Sedation on Cognitive Function After LAOO: An Observational Study
Rochester, Minn.,
Eau Claire, Wis.
The purpose of this study is to assess the impact of sedation strategy on cognitive outcomes after left atrial appendage occlusion (LAAO) occlusion with the WATCHMAN FLX™ or AMULET device.
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Prognostic Ability of Magnetocardiography (MCG) in Patients Undergoing Cardiac Catheterization
Rochester, Minn.
The purpose of this study is to measure the utility of Magnetocardiography (MCG) using the Mesuron Avalon-H90 MCG device in discerning underlying myocardial disease in patients presenting to the Catheterization Laboratory for coronary angiography, hemodynamic studies, or myocardial biopsy.
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Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion with the Watchman Device: The ICE WATCHMAN study (WATCH-ICE)
Rochester, Minn.
The aim of this multi-center study will be to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance. By eliminating the need for general anesthesia, we hope to show a reduction in procedural time, decrease use of supplemental invasive procedures (central venous line, invasive arterial pressure monitoring and transesophageal echocardiography) and quicker patient recovery time. This approach can decrease healthcare resource utilization and safely simplify left atrial appendage closure with the WATCHMAN device.
Closed for Enrollment
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A 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 Replacement (PARTNER 3)
Rochester, Minn.
The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients who have severe, symptomatic aortic stenosis and are at low operative risk for standard aortic valve replacement.
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Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis (EARLY TAVR)
Rochester, Minn.
This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.
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P3-AVIV is a Prospective, Single-arm, Multicenter Clinical Trial That Will Establish the Safety and Efficacy of SAPIEN 3/SAPIEN 3 Ultra THV in Patients With a Failing Aortic Bioprosthetic Valve (P3-AVIV)
Rochester, Minn.
To assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.
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PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
Rochester, Minn.
The purpose of this study is to assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
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Staging Classification of Moderate to Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
Rochester, Minn.
The purpose of this study is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in your heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).
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The Partner II Trial: Placement of Aortic Transcatheter Valves Trial (US) Edwards Study 2010-12 (PARTNER II)
Rochester, Minn.
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
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The Philips ICE Registry-ICE-Guided Cardiac Interventional Percutaneous Procedures
Rochester, Minn.
The purpose of this study is to demonstrate the performance and safety of intracardiac echocardiography (ICE) system to guide cardiac interventional percutaneous procedures when used according to its instructions for use (IFU) in standard clinical practice.
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WATCHMAN FLX versus NOAC for EMbolic ProtectION in the Management of Patients with Non-Valvular Atrial Fibrillation
Rochester, Minn.
The primary objective of this study is 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.
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Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR) (WATCH-TMVR)
Rochester, Minn.
This investigation constitutes a feasibility study involving assessing the safety and feasibility of combining clinically indicated Left Atrial Appendage Occlusion (LAAO) and Transcatheter Mitral Valve Repair (TMVR) in one setting using approved devices.
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