Reveal In-Office Implants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01168427
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : July 26, 2012
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment
Arrhythmias, Cardiac Device: Reveal® DX or Reveal® XT Insertable Cardiac Monitor

Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reveal® In-Office Implants Study
Study Start Date : August 2010
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants Having Procedure-related Adverse Events [ Time Frame: 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).

  2. Surgical Staff Utilized for Reveal In-office Implants [ Time Frame: At implant ]
    Observational analysis of surgical staff present at the Reveal Implants

  3. Techniques and Procedures Utilized During Reveal In-office Implants [ Time Frame: 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.

  4. Physician Satisfaction With Reveal In-office Implants [ Time Frame: At implant ]
    Observational survey of physicians satisfaction post implant At implant

  5. R-wave Amplitude Measurement [ Time Frame: Implant procedure and 30 days post-implant procedure ]
    Average R-wave amplitude at implant and 30-days post procedure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients recruited for participation in study were indicated for continuous arrhythmia monitoring.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01168427

United States, California
La Jolla, California, United States
United States, Florida
Miramar, Florida, United States
United States, Georgia
Macon, Georgia, United States
United States, Indiana
Munster, Indiana, United States
United States, Maryland
Takoma Park, Maryland, United States
United States, North Carolina
Greensboro, North Carolina, United States
United States, Ohio
Kettering, Ohio, United States
United States, Texas
Amarillo, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Study Chair: Reveal In-Office Implants Clinical Research Specialist Medtronic

Vater M., Rameken M., Pitschner H.F., et al. The endless-loop-recorder in clinical practice - Results of the multicentre German Reveal® registry. Herzschrittmachertherapie und Elektrophysiologie (2002) 13:2 (101-109).

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure Identifier: NCT01168427     History of Changes
Other Study ID Numbers: Reveal In-Office Implants
First Posted: July 23, 2010    Key Record Dates
Results First Posted: July 26, 2012
Last Update Posted: February 28, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes