Reveal In-Office Implants

Reveal® In-Office Implants Study

The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional hospital operating room, cardiac catheterization or electrophysiology (EP) laboratory setting.

Inclusion Criteria:

• Patient is indicated for continuous arrhythmia monitoring with an Insertable Cardiac Monitor (ICM)
• Patient is willing to undergo implant in clinic setting with only local anesthetic and/or oral anti-anxiety medications for sedation
• Patient is 18 years of age or older
• Patient is willing and able to provide consent and authorize the use and disclosure of health information
• Patient is willing and able to comply with the protocol including the required follow-up

Exclusion Criteria:

• Patient has reduced immune function or is otherwise at high risk for infection
• Patient has had a recent (within 30 days) or otherwise unresolved infection
• Patient is implanted or indicated for implant with a pacemaker, Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or hemodynamic monitoring system
• Patient is participating in another clinical study that may have an impact on the study endpoints
• Patient's life expectancy is less than 1 year
• Patient is pregnant
• Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure