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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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Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (HEAL-IST)
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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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).
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