Clinical trial NCT01168427: Reveal In-Office Implants
Official title: Reveal® In-Office Implants Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients recruited for participation in study were indicated for continuous arrhythmia monitoring.

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.


Eligibility criteria: 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 outcomes:
measure: Procedure-related Complications Rate Requiring Resolution by Surgical Intervention
timeFrame: From Implant to 90 days post-implant procedure
Secondary outcomes:
measure: Number of Participants Having Procedure-related Adverse Events
timeFrame: From Implant to 90 days post-implant procedure
measure: Surgical Staff Utilized for Reveal In-office Implants
timeFrame: At implant
measure: Techniques and Procedures Utilized During Reveal In-office Implants
timeFrame: At implant
measure: Physician Satisfaction With Reveal In-office Implants
timeFrame: At implant
measure: R-wave Amplitude Measurement
timeFrame: Implant procedure and 30 days post-implant procedure
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Miramar
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: Munster
country: United States
state: Indiana
city: Takoma Park
country: United States
state: Maryland
city: Greensboro
country: United States
state: North Carolina
city: Kettering
country: United States
state: Ohio
city: Amarillo
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Medtronic
name: Reveal In-Office Implants Clinical Research Specialist
role: STUDY_CHAIR
References:
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