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A Study of the CardioFocus Endoscopic Ablation System (HeartLight) in Patients with Atrial Fibrillation
Jacksonville, FL
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.
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TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
No Locations
The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing capability. Patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic AF between the two study arms. Additional measures of treatment success including quality of life, recurrence of asymptomatic AF and procedural efficiency will also be studied.
A second phase of the study will treat up to ...
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A Study to Evaluate Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure with Preserved Ejection Fraction
Rochester, MN
The objective of this clinical evaluation is to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).
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A Study to Evaluate Long-term Outcomes of Alcohol Septal Ablation for Hypertrophic Cardiomyopathy
Rochester, MN
The purpose of this study is to determine long term vital status, symptoms, and need for repeat procedure after alcohol septal ablation, to determine patient and procedural factors associated with successful alcohol septal ablation and need for repeat procedure, and to determine the impact of conduction abnormalities after alcohol septal ablation on long-term outcomes.
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Saline-Enhanced Radiofrequency Catheter Ablation for the Treatment of Ventricular Tachycardia
No Locations
The purpose of this study is to demonstrate the technical feasibility of the Saline-Enhance Radiofrequency (SERF) Catheter and SERF Cardiac Ablation System to eliminate or control ventricular tachycardia (VT).
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A Study to Evaluate the Adagio System to Treat Persistent Atrial Fibrillation
Jacksonville, FL
The purpose of this study is to provide safety and effectiveness data regarding the use of the Adagio System in the treatment of Persistent Atrial Fibrillation (PsAF).
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Recovery of Left Ventricular Systolic Function and Atrial Fibrillation Recurrence after Restoration of Sinus Rhythm in Patients with Atrial Fibrillation
Rochester, MN
The objectives of this study are: (1) to analyze beat-to-beat variability and the variations of R-R interval to pre-preceding R-R interval (RRp/RRpp) ratio of left ventricular (LV) function by strain imaging (2D speckle tracking echocardiography) in patients with atrial fibrillation (AF) undergoing electrical cardioversion(ECV) or radiofrequency catheter ablation (RFCA) as a predictor of a recovery of LV function and volume after restoration of sinus rhythm , (2) to evaluate left atrial mechanics as a predictor of for AF recurrence after electrical cardioversion (ECV) or radiofrequency catheter ablation (RFCA)
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Imaging Integration Into Electroanatomic Mapping for Catheter Ablation Procedures of Ventricular Arrhythmias
Rochester, MN
The aim of the present study is to assess the use of high-resolution imaging data from CT and or MRI processed in 3D meshes with the use of the MUSIC software (inHEART, Bordeuax, France) and integrated within the EP lab environment to assist catheter ablation procedures. The MUSIC software is a proprietary software developed by cardiac electrophysiology and radiology researchers at the University of Bordeuax, France, that allows high-resolution recostruction of CT and MRI cardiac imaging for integration into electroanatomic maps in ablation procedures2,3.
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A Study of the FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
Rochester, MN
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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A Study to Evaluate the Use of The Sentinel Device During Atrial Fibrillation Ablation
Rochester, MN
The purpose of this study is to compare the Sentinel® Cerebral Protection System to the standard of care (no cerebral protection) in patients undergoing atrial fibrillation (AF) catheter ablation.
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Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY
Rochester, MN
The purpose of this study is to assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
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Ventricular Arrhythmia Increases Sympathetic Activity Determined By A Skin Nerve Recording
Rochester, MN
The purpose of this study is to utilize neuECG, a new method to directly and non-invasively record skin sympathetic nerve activity (SKNA) and electrocardiogram (ECG), to non-invasively assess the effects radiofrequency catheter ablation (RFCA) on SKNA in patients at high risk for life-threatening ventricular arrhythmias (VA).
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Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
No Locations
This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
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Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia
No Locations
The purpose of this study is to demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.
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Novel Cardiac Signal Processing System
Jacksonville, FL
This study involves the use of the Pure EP system in parallel to standard cardiac signal equipment during cardiac ablation procedures. The recordings/mapping from both systems will be reviewed and compared to determine if the Pure EP system can provide better or clearer diagnostic information.
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Efficacy and Safety of Intranasal MSP-2017 for the Conversion of PSVT to Sinus Rhythm (NODE-1)
Scottsdale/Phoenix, AZ
The primary objective of this study is to demonstrate the superiority of at least 1 dose of intranasal MSP-2017 over placebo in terminating paroxysmal supraventricular tachycardia induced in an electrophysiology laboratory
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A Study to Evaluate Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat Atrial Fibrillation (AF)
Rochester, MN
The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelectTM PFA System for the treatment of paroxysmal and persistent atrial fibrillation.
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A Study of Silent Cerebral Lesions in Patients Undergoing Left Heart Ablation for Ventricular Arrhythmia and Atrial Fibrillation
Rochester, MN
The purpose of this study is to learn about the effect of atrial fibrillation on memory and thinking. This study helps us to determine how often memory problems occur in patients with atrial fibrillation and identify factors that influence changes in memory and thinking.
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Colchicine and CRP in Atrial Fibrillation and AF Ablation
No Locations
Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation
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A Study to Evaluate the Safety and Effectiveness of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
No Locations
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
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Registration of Coronary Arteries through Electroanatomical Mapping System with CT Angiography
Rochester, MN
This study aims to perform a prospective analysis of patients undergoing fibrillation ablations and compare the validity of the electroanatomical registration with superimposed angiography. In addition, this study aims to compare and understand the relationship between the cardiac vessels.
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Transcatheter Pulmonary Valve Replacement and Catheter Ablation of Ventricular Tachycardia in Tetralogy of Fallot
Jacksonville, FL; Rochester, MN
The aim of this study is to determine the outcomes of catheter ablation before transcatheter PVR among patients with Tetralogy of Fallot (TOF, a specific type of congenital heart defect). It is hypothesized that a combination of successful catheter ablation and transcatheter PVR placement will result in a reduction in a conventional risk score calculation (and consequently, fewer patients meeting criteria for primary prevention ICD placement) owing to a combination of VT circuit elimination and favorable RV remodeling.
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Novel Artificial Intelligence-Assisted Image-Guided Radioablation for Ventricular Tachycardia
Jacksonville, FL
The purpose of this study is to determine if nonInvasive cardiac radioablation (NICRA) can provide selective access to deeper scarred myocardial tissue for ablation.
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A Study of Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death
Rochester, MN
The purpose of this study is to evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death.