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Assessment of Utility of Siemens AcuNav Crystal ICE Catheter in Evaluation of Cardiac Anatomy and Physiology During Electrophysiology and Structural Heart Interventional Procedures
Rochester, Minn.
The purpose of this study is to guide product development for AcuNav Crystal ICE catheters.
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Functional ElectroAnatomiC Isochronal Late Activation Mapping For Empiric VT Ablation Trial
Rochester, Minn.
This is a multicenter, prospective, parallel, randomized controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to conventional voltage- based ablation. The study has two treatment arms: conventional voltage mapping and ablation (control arm). In the investigational arm, the ablation strategy is guided by ILAM to target deceleration zones, blinded to voltage mapping. In the control arm, ablation will be performed to extensively ablate all low voltage regions (\<1.5mV) during sinus rhythm, right ventricular (RV) pacing, or left ventricular (LV) pacing, with discretionary use of pacemapping and activation mapping. In both arms, mapping with be performed with a multielectrode catheter (HD Grid) and ablation will be performed using an irrigated tip catheter (FlexAbility SE or Tactiflex catheters).
In the control armonly voltage mapping displays will be utilized (blinded to functional ILAM and fractionation). High density mapping with automated last deflection annotation (Ensite X) will be performed in all patients randomized to ILAM approach during either sinus rhythm or RV pacing.
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Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study
Rochester, Minn.
The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).
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
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
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
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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Hybrid Epicardial And Endocardial Sinus Node Sparing Ablation Therapy For Inappropriate Sinus Tachycardia
Rochester, Minn.
The purpose of this study is to evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure for the treatment of symptomatic drug refractory or drug intolerant inappropriate sinus tachycardia (IST).
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Post-Market Real World Outcomes In WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device
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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