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Micra Transcatheter Pacing Study
Rochester, MN
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.
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Superficial Cervical Plexus Block for Pacemaker Insertion
Jacksonville, FL
The purpose of this study is to investigate clinical outcomes from two current standard of care pain control procedures performed for patients undergoing pacemaker insertion.
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A Study for the Continued Access of the Micra Transcatheter Pacing System
Rochester, MN
Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).
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Aveir DR i2i Study
Rochester, MN
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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The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
Rochester, MN
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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Ferromagnetic Detection of Cardiac Devices using a Metrasens Screener
Rochester, MN
The purpose is to conduct a study that determines the efficiency of FMDS in pre MRI screening for detecting cardiac implants in a Mayo Clinic environment.
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A Study Comparing Edoxaban to Warfarin Therapy When Used for Cardiovascular Implantable Electrical Device Procedures in Patients with a Non-Valve Related Atrial Fibrillation
Scottsdale/Phoenix, AZ
The purpose of this study is to compare the safety and effectiveness of Edoxaban to Warfarin when used in patients with a non-valve related atrial fibrillation undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.
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Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli
Rochester, MN
Patients with a patent foramen ovale in the setting of endocardially placed cardiac implantable electronic devices such as pacemakers, defibrillators, or resynchronization therapies are likely at higher risk for paradoxical embolic events from device lead thrombus. The investigators are conducting this study to determine if the anticoagulant medication Apixaban is more effective at reducing MRI detected brain lesions compared to placebo.
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Prediction of Chronic Pacemaker/ICD Threshold by Increased Pulse Width Duration Pacing
Scottsdale/Phoenix, AZ
The aim of this study is to evaluate the relation of the acute pacing threshold (volts at ‘x’ pulse width) to the chronic pacing threshold of a pacemaker/ICD lead by studying the threshold during implantation at different pulse widths (eg. Twice of ‘x’, Three times of ‘x’).
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A Study to Compare the Rate of Major Cardiovascular Implantable Electronic Device Infections with the Absorbable Antibacterial Envelope and without
Rochester, MN
The purpose of this study is to evaluate the ability of the TYRX Absorbable Antibacterial Envelope to reduce major cardiovascular implantable electronic device infections through 12-months post-procedure following generator replacement, upgrade, revision, or new CRT-D implant.
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Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
Rochester, MN
Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO) and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the wall separating the right and left sides) of the heart. The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform Septal Occluder in people with an endocardial device leads reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack ...