Clinical Trials

The primary purpose of this study is to explore KardiaK performance in a controlled and comprehensive clinical setting, including collection of relevant data such as patient medical history, and medications affecting potassium.  In addition, it is intended to explore KardiaK performance when serial ECGs are recorded and to explore KardiaK performance using a 12-lead ECG and two novel ECG recording devices designed for home use.

Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the identification of STEMI (ST Elevation Myocardial Infarction).

The objective of this study is to evaluate ECG based AI predictions for clinical pathologies across ECG device types. The ECG is a test that records your heart’s rhythm. The goal is to evaluate the impact of ECG device type on AI-based heart disease predictions.

The purpose of this study is to determine the performance of AI-ECG as a screening tool in clinical practice identifying patients with moderate or severe AS, to determine the ability of POCUS in detecting moderate or severe AS amongst in patients with positive AI-ECG.

Additionally, to identify which clinical features (presence of cardiac murmur, prevalence of hypertension, age or sex) can improve decision making process of applying echocardiography exam in patients with positive AI-ECG.

The purpose of this study is to modify and adapt the algorithm to be usable in a mobile form factor with a limited number of leads. For this, will prospectively test and validate the adapted algorithm in outpatients presenting to the echocardiography laboratory and to test the sensitivity and specificity of a single lead ECG to identify people with decreased left ventricular EF.

The purpose of this study is to show the artificial intelligence enhanced single-lead ECG Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI enhanced single lead (LI) of a 12 lead ECG.

The purpose of this study is to examine that signal processed ECGs can be used to monitor changes in serum concentrations of potassium based on T-wave features.

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 ...

The purpose of this study is to refine the technique for non-invasively determined potassium measurement and to determine whether or not the technique can be realized in a single channel-subcutaneous ECG implementation modality.

The purpose of this study is to validate the real-world performance of our previously developed AI-ECG algorithm for identification of hyperkalemia with a six-lead mobile-enhanced device  

Ambulatory adult patients at increased risk for hyperkalemia due to age ≥ 50 years, and one or more criteria including eGFR (from serum creatinine) < 45="" ml/minute="" and/or="" a="" history="" of="" serum="" potassium=""> 5.2 mEq/l, who present to the emergency department will be approached to consent for our rapid screening process.

The purpose of this study is to determine the feasibility and effectiveness of electrocardiogram (ECG) to detect a form of heart failure among women of childbearing age (ages 18-49 years). 

Heart disease is the leading cause of mortality during peripartum and postpartum period. Screening for heart disease during pregnancy, however, is a significant unmet need. If proven to be effective, this test can be used as a screening tool for early detection of heart failure among women who are contemplating pregnancy, currently pregnant or recently delivered a child. 

The purpose of this study is to evaluate the accuracy of wireless multi-lead AliveCor device, in seated and supine position, with traditional ECG and to evaluate the accuracy of the wired multi-lead AliveCor device, in seated and supine position, with traditional EDG.

The purpose of this study is to assess cardiovascular health and detect unknown and asymptomatic diseases using Mayo AI-ECG algorithms.

We hypothesize that using single lead ECGs and symptoms data collected by patients using their personal Apple Watch (FDA approved for AF detection) via a Mayo Clinic app, will allow data to be shared within a dashboard in Epic, so physicians may have a way to remotely assess cardiovascular health.

The purpose of this study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.

The overarching goal is to provide a means to evaluate cardiac allograft rejection non-invasively and remotely. This can be used to identify and prioritize patients that need to visit Mayo Clinic frequently following a heart transplant based on the likelihood of cardiac allograft rejection.

The purpose of this study is to assess the feasibility of using the current FDA-approved AliveCor Kardia device and their AliveCor Tripod device (FDA Approval pending) to measure the QT/QTc in patients presenting to the Genetic Heart Rhythm Clinic.

This study is designed to investigate the AliveCor’s ability to record the heart’s electrical activity similar to other lead configurations.

The purpose of this study is to evaluate diagnostic accuracy of the EKO DUO System in patients with Genetic Heart Diseases and develop novel algorithms to diagnose these conditions. The device will be placed on the chest (similar to a stethoscope exam) and will simultaneously record an ECG and phonocardiogram (PCG) for up to 120 seconds. Additional data obtained will include clinical characteristics, past medical history, recent medications and procedure, laboratory data, and echocardiographic and ECG studies.

Tools like the EKO Duo device can be used to improve diagnosis and risk stratification in patients with genetic heart diseases (GHDs).

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.

The purpose of this study is to evaluate the effects of GBT440 on the body and oxygen saturation levels , assessed at rest and at maximum exercise under conditions of low oxygen in the atmosphere.

The purpose of this study is to use a noninvasive method of recording together skin sympathetic nerve activity and electrocardiogram (ECG) to assess the sympathetic activity of the heart. The potential use of this is in the prediction of ventricular arrhymia and identifying the response to resynchronization therapy.

The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on 12 lead electrocardiogram (ECG),a positive family history and/or characteristic arrhythmias and confirmed by genetic testing.  LQTS testing cannot be performed successfully before birth as   fetal ECG is not possible and direct measure of the fetal QT interval by magnetocardiography is limited. Genetic testing can be performed in utero, but there is risk to the pregnancy and the fetus. Although some fetuses present with arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular (AV) block, this is uncommon, occurring in <25% of fetal ...

The purpose of this study is to determine if it is possible to record a high quality fetal ECG using signals acquired inside of the birth canal (vagina). 

The purpose of this study is to determine the accuracy of a non-invasive approach to estimate potassium levels using surface ECG's from patients undergoing hemodialysis.

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 purpose of this study is to gather information to understand the effect of body position on ECGs using artificial intelligence.

The purpose of this study is to prospectively evaluate a newly-developed screening tool for ALVSD.

The purpose of this study is to evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.