Surescan Pacing System Post-Approval Study

Study Status

Open to Enrollment

Study Description

Pacemakers are electronic devices that are designed to prevent the heart from going too slowly. They are used primarily in people whose normal pacemakers are either diseased or suppressed by drugs, or in whom the connection between the upper and lower chambers of the heart---what’s called the cardiac conduction system, may be abnormal, producing a situation known as heart block.

Therefore the primary purpose of a pacemaker is to measure each heartbeat and to actually inject an electrical stimulus into the heart which causes a heartbeat if the heartbeat becomes too slow. Pacemakers do not prevent rapid heartbeats. In some situations, particularly when they exist in an implantable defibrillator, they may be used to treat rapid heart beats, but their primary indication is to prevent the heart from going too slowly.

The SureScan IPG model is a market released, dual chamber IPG model that is based on the EnRhythm IPG. In the pre-market clinical study, SureScan was named EnRhythm MRI SureScan IPG Model EMDR01. The study sponsor Medtronic then changed the name to REVO MRI SureScan Pacemaker (IPG) Model RVDR01 at U.S. market release. The market released SureScan pacing system is therefore comprised of the Revo MRI SureScan pacemaker (IPG) Model RVDR01 and the CapSureFixMRI active fixation lead Model 5086MRI or the EnRthythm MRI SureScan IPG Model EMDR01 and the 5086MRI lead.

The Model 5086MRI lead is indicated for use in both the atrium and ventricle. Subjects may undergo MRI scans when the system is used in accordance with the labeling associated with MRI compatibility. It senses the electrical activity of the patient’s heart using the sensing electrodes of the implanted leads. Then it analyzes the heart rhythm based on selected sensing and detection tachycardia pacing (ATP) therapy. IF the IPG identifies a bradyarrhythmia, it delivers bradycardia pacing therapy.

The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling.  SureScan PAS is designed to monitor long-term performance of the SureScan pacing system.

Sponsor

Medtronic

Key Eligibility

  • People who have been or intend to be implanted with a complete SureScan Pacing System consisting of both a right atrial and ventricular 5086 MRI lead (used for pacing and sensing) and a SureScan device

Principal Investigator

Jim Cheung, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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