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  • Transcatheter Pulmonary Valve Replacement and Catheter Ablation of Ventricular Tachycardia in Tetralogy of Fallot Jacksonville, Fla., Rochester, Minn.

    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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  • Arrhythmia in Eisenmenger’s Syndrome Rochester, Minn., Jacksonville, Fla.

    The purpose of this study is to describe the incidence and type of arrhythmia seen in patients with Eisenmenger syndrome, to define predisposing factors potentially leading to the onset of arrhythmia, and to describe the influence of arrhythmia on outcomes.
  • Effect of Myectomy on the Sudden Cardiac Death Risk in Hypertrophic Cardiomyopathy Rochester, Minn.

    The primary purpose/objective of this study is to determine whether myectomy as a management option for severe hypertrophic cardiomyopathy (HCM) reduces the incidence of sudden cardiac death.

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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.
  • An Observational, Multicentre Study to Evaluate the Feasibility of a Novel Mobile Health Monitoring Platform to Capture Patient-centered Outcomes Measures Among Patients With Heart Failure (HF) Jacksonville, Fla. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Patients with HF have reduced function capacity and quality of life (QoL) and hence it is imperative to explore interventions that impact endpoints that directly measure how a patient feels or functions on a daily basis. Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms. These technologies are able to capture and integrate data from disparate sources from individual patients reflecting their functional status and symptomatology. These data can potentially serve as surrogate endpoints for approval of new HF therapies. In this study, the investigators will test the feasibility of a novel mobile health monitoring platform to capture patients' physiology, functional capacity and assessment of quality of life.
  • PURE EP 2.0 Novel Cardiac Signal Recording System for Electrophysiology Procedures Jacksonville, Fla.

    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.
  • Remote Wearable-Based Diagnosis for Patients with Postural Orthostatic Tachycardia Syndrome (POTS) Jacksonville, Fla.

    The purpose of this study is to test the feasibility of using a novel wearable biosensor and mobile health monitoring platform to capture patients’ physiology, functional capacity and assessment of symptoms, thereby building a profile of Positional Orthostatic Tachycardia Syndrome (POTS) while excluding more serious cardiac, neurological and endocrine causes for their symptomatology. We hypothesize that as a non-fatal condition, a complete physiological profile of the POTS patients can be built entirely remotely therefore avoiding the need for these patients to visit the hospital and clinic.
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