Reveal In-Office Implants

NCT ID: NCT01168427

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-05-31

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.

Conditions

Arrhythmias, Cardiac

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reveal In-Office Implants Clinical Research Specialist

Role: STUDY_CHAIR

Medtronic

Locations

La Jolla, California, United States

Miramar, Florida, United States

Macon, Georgia, United States

Munster, Indiana, United States

Takoma Park, Maryland, United States

Greensboro, North Carolina, United States

Kettering, Ohio, United States

Amarillo, Texas, United States

San Antonio, Texas, United States

Countries

United States

References

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Other Identifiers

Reveal In-Office Implants

Identifier Type: -

Identifier Source: org_study_id