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Aveir Dual-Chamber Leadless i2i IDE Study
Rochester, Minn.
The purpose of this study is to evaluate the safety and effectiveness of the AveirTM Dual-Chamber (DR) Leadless Pacemaker (LP) system in patients indicated for a DDD(R) pacemaker to support regulatory approval for the Aveir DR LP system for DDD(R) pacing indications and the Aveir atrial LP for AAI(R) pacing indications.
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Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
Rochester, Minn.
The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG).
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Detection of Reduced Left Ventricular Ejection Fraction with Single Lead ECG Using Artificial Intelligence
Rochester, Minn.
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.
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ECG Monitoring using Tripod/Kardia leaded and leadless for Monitoring Potassium Levels in Patients with Cardiac and Renal Disease
Rochester, Minn.
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.
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Estimation of Body Position Using Artificial Intelligence from Standard 12-lead ECGs
Rochester, Minn.
The purpose of this study is to gather information to understand the effect of body position on ECGs using artificial intelligence.
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Pilot Study of Artificial Intelligence Algorithm for Detection of Hyperkalemia in the Emergency Department Using Multilead ECG Devices
Rochester, Minn.
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.
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Potassium and Cardiac Rhythm Trends in Maintenance Hemodialysis (PORTEND): A Multicenter, Prospective, Observational Study (PORTEND)
Rochester, Minn.
The purpose of this study is to assess the serum potassium and cardiac rhythm trends in subjects with end stage renal disease (ESRD) who are on 3 times weekly maintenance hemodialysis for at least 60 days.
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Remote Monitoring of Patients with a Nanostim Leadless Pacemaker Utilizing a Smartphone Enabled ECG
Rochester, Minn.
The purpose of this study is to observe the remote ECG signals of Nanostim pacemaker patients utilizing the AliveCor device, and compare these ECG signals with ECG recordings collected with the Nanostim device programmer during their clinical follow-up.
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Smartphone Enabled Home Screening for COVID-19 Using Electrocardiogram (ECG), Dried Blood Spot (DBS) and Mid-Turbinate NasAL Swab (SIGNAL)
Rochester, Minn.
An important means to control the COVID-19 pandemic is the rapid identification of infected individuals to allow quarantine and therapy to be promptly delivered. At home testing will soon be available, but requires reagents and introduces a delay. The possibility of combining a limited number of Mid-Turbinate (MT) nasal swab tests, Dried Blood Spot (DBS) serology, and smartphone-enabled electrocardiogram (ECG) tests may permit daily rapid, under one minute tests potentially, if this method proves to be effective. We plan to enroll 900 participants to determine if we can detect conversion in all modalities.
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ST Monitoring to Detect ACS Events in ICD Patients (AnalyzeST)
Rochester, Minn.
This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.
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The LEADLESS II Study - A safety and effectiveness trial for a leadless pacemaker system (LEADLESS II)
Rochester, Minn.
Prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.
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