Reveal In-Office Implants

Completed

Conditions studied: Arrhythmias, Cardiac

In brief

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.

Key facts

Study ID

NCT01168427

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

66

Starts

2010-08-01

Expected to finish

2011-05-01

Last updated by the study team

2018-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — La Jolla, California, United States
• Study site — Miramar, Florida, United States
• Study site — Macon, Georgia, United States
• Study site — Munster, Indiana, United States
• Study site — Takoma Park, Maryland, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Kettering, Ohio, United States
• Study site — Amarillo, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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