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Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study
Rochester, Minn.
The goal of this clinical trial is to compare the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices. This procedure is for patients with non-valvular atrial fibrillation who are at increased risk for stroke, but have a reason to seek an alternative to blood thinning medications. This clinical trial will compare the safety and efficacy of the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices.
Participants in this trial will be randomly assigned one-to-one (like flipping a coin) for treatment with either the Laminar Left Atrial Appendage Closure System or a commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).
Closed for Enrollment
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(EpiAcc Registry) Percutaneous Epicardial Access Registry (EpiAcc Registry)
Rochester, Minn.,
Jacksonville, Fla.
This study will look at patient and procedural characteristics of those undergoing EpiAcc, as well as outcomes of procedures using EpiAcc.
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A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation (AVANT GUARD)
Rochester, Minn.
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.
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Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation (OPTION)
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 oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
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Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY (EASY AF)
Rochester, Minn.
The purpose of this study is to assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
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FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study (LESS-VT)
Rochester, Minn.
The purpose of this study is to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.
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Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (HEAL-LAA)
Rochester, Minn.
The purpose of this study is to collect real-world outcomes data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients who are implanted with the WATCHMAN FLX Pro device in a commercial clinical setting.
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WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy
Rochester, Minn.
The purpose of this study is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.
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