NCT01168427CompletedNot Applicable
Reveal® In-Office Implants Study
Medtronic Cardiac Rhythm and Heart Failure0 sites66 target enrollmentStarted: August 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Primary Endpoint
- Procedure-related Complications Rate Requiring Resolution by Surgical Intervention
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Procedure-related Complications Rate Requiring Resolution by Surgical Intervention
Time Frame: 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 Outcomes
- Number of Participants Having Procedure-related Adverse Events(From Implant to 90 days post-implant procedure)
- Techniques and Procedures Utilized During Reveal In-office Implants(At implant)
- R-wave Amplitude Measurement(Implant procedure and 30 days post-implant procedure)
- Surgical Staff Utilized for Reveal In-office Implants(At implant)
- Physician Satisfaction With Reveal In-office Implants(At implant)
Investigators
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