Peter A. Noseworthy, M.D., M.B.A.

The purpose of this study is to characterize the clinical course of implantable cardioverter-defibrillator (ICD) patients using interviews, EHR review, and remote monitoring to develop a rich dataset containing many outcomes of interest.  

The TRACER-ICD Study will be a 60 month study (9 months preparation, 45 months to conduct the study, 6 months data analysis and manuscript preparation) in which a prospective cohort of 500 patients receiving ICDs as part of clinical care at 5 sites will be followed for up to 18 months or death, with data collected from patient or proxy interviews (baseline, in-person; quarterly, by telephone) and electronic record reviews (baseline and quarterly), including remote monitoring data. Data collected through these complementary methods will be used to describe the following aspects of patients’ clinical course:

• focused geriatric assessment (e.g., frailty, cognition, functional status);
• comorbidities;
• quality of life;
• advance care planning;
• health services use;
• SDM;
• ICD-recorded physical activity (minutes/day).
• Factors associated with death and poor quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ] score < 60 or decline by > 10) will be identified. Group-based trajectory modeling will be used to identify clusters of patients with distinct trajectories of functional status and quality of life following ICD implantation (Aim 1). We will validate our semi-competing risks model to jointly assess ICD shocks and survival (Aim 2). Lastly, we will combine quantitative data on SDM experiences from the main cohort with semi-structured interviews of cardiologists and patients to evaluate strategies for incorporating personalized profiling into SDM (Aim 3).

The purpose of this study is to compare electrocardiograms performed in the downtown Mayo Clinic out-patient practice between two different devices: the remote 12-lead ECG Smartheart Device and the standard of care 12-lead ECG GE Machine.

An electrocardiogram, also called ECGs or EKGs, records the electrical signals in your heart. These tests are often done in a doctor’s office, a clinic, or a hospital room. ECG machines are also standard equipment in operating rooms and ambulances. The cost and complexity of existing diagnostic electrocardiography technologies makes them incompatible with widespread stand of care in the primary care settings.

The FDA-approved Smartheart 12-lead ECG Device shows that this standard testing can be performed remotely without the assistance of a well-adverse nurse or technician. This device transmits a single remote 12-lead ECG to an electronic platform for analysis.

Our hypothesis is A.I.-ECG interpretation models will perform similarly or outperform current GE computer ECG interpretation software.

1. Obtain AliveCor ECG Recordings from subjects at the time of clinically indicated ECGs over the course their anti-arrhythmic drug loading hospital admission. 
2. Create and refine an AliveCor algorithm to accurately measure a patient’s QT interval and heart rate corrected QTc value and validate/compare the results against the 12- lead ECGs on record.
3. Obtain AliveCor ECG recordings at the time of daily clinically indicated electrolyte panels to further develop and refine a Potassium screening algorithm.

Is the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) superior to the current state-of-the-art therapy with either rate control or rhythm control drugs for a) reducing the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest (primary endpoint; previously the key secondary endpoint) and b) decreasing total mortality (secondary endpoint; previously the primary endpoint) in subjects with untreated or incompletely treated AF warranting therapy?

The purpose of this study is to help researchers better understand the impact of wearable devices on patient experience and clinical trends following a cardioversion.

The purpose of this study is to assess the ability of common genetic variants in aggregate to predict drug-induced QT prolongation in patients being started on dofetilide. We will examine the predictiveness of a QT genotype score on QT prolongation in patients admitted for dofetilide initiation.
 

The main objective of this study to assess the quality of the ECG readings between different filters from both the GE machine and the Smartheart device. 

The primary objective of this study is to determine whether etripamil nasal spray (NS) 70 mg is superior to placebo at terminating episodes of PSVT in an outpatient setting.

The primary objective of this study is to determine whether etripamil nasal spray (NS) 70 mg is superior to placebo at terminating episodes of Paroxysmal Supraventricular Tachycardia (PSVT) in an outpatient setting.

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.

The overall goal of this study is to investigate the use of artificial intelligence (AI) techniques as a screening tool for cardiomyopathies in pregnancy and the post-partum period.

The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.

The purpose of this study is to evaluate the safety of etripamil nasal spray in patients with Paroxysmal Supraventricular Tachycardia (PSVT). Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.

The purpose of this study is to determine if common genetic variants that underlie the QT interval are also associated with medication-induced torsade de pointes (TdP).

The goal of this study is to support the development of a tiered inpatient cardiac telemetry program and leverage technologies to work toward the capability for all general care beds to have a plug-and-play cardiac monitoring.

The objective of this study is to test and validate InfoBionic inpatient telemetry technology.  Patients will be simultaneously monitored using Philips and InfoBionic technology to compare service, technology and inform future build.