Reveal In-Office Implants

Study Overview
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Brief Summary
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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.

Official Title
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Reveal® In-Office Implants Study

Conditions
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Arrhythmias, Cardiac

Intervention / Treatment
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* Device: Reveal® DX or Reveal® XT Insertable Cardiac Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Reveal® DX or Reveal® XT Insertable Cardiac Monitor|Reveal® DX and Reveal® XT Insertable Cardiac Monitors are implantable patient-activated and automatically-activated monitoring systems that record subcutaneous ECG.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related Complications Rate Requiring Resolution by Surgical Intervention | 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. | From Implant to 90 days post-implant procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Having Procedure-related Adverse Events | 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). | From Implant to 90 days post-implant procedure | 
| Surgical Staff Utilized for Reveal In-office Implants | Observational analysis of surgical staff present at the Reveal Implants | At implant | 
| Techniques and Procedures Utilized During Reveal In-office Implants | 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. | At implant | 
| Physician Satisfaction With Reveal In-office Implants | Observational survey of physicians satisfaction post implant At implant | At implant | 
| R-wave Amplitude Measurement | Average R-wave amplitude at implant and 30-days post procedure | Implant procedure and 30 days post-implant procedure |