Reveal In-Office Implants

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Procedure-related Complications Rate Requiring Resolution by Surgical Intervention	From Implant to 90 days post-implant procedure	This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Having Procedure-related Adverse Events	From Implant to 90 days post-implant procedure	Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention).
Techniques and Procedures Utilized During Reveal In-office Implants	At implant	Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time.
R-wave Amplitude Measurement	Implant procedure and 30 days post-implant procedure	Average R-wave amplitude at implant and 30-days post procedure
Surgical Staff Utilized for Reveal In-office Implants	At implant	Observational analysis of surgical staff present at the Reveal Implants
Physician Satisfaction With Reveal In-office Implants	At implant	Observational survey of physicians satisfaction post implant At implant