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Reveal In-Office Implants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01168427
First received: July 21, 2010
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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 Intervention
Arrhythmias, Cardiac
Device: Reveal® DX or Reveal® XT Insertable Cardiac Monitor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Reveal® In-Office Implants Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Procedure-related Complications Rate Requiring Resolution by Surgical Intervention [ Time Frame: From Implant to 90 days post-implant procedure ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Having Procedure-related Adverse Events [ Time Frame: From Implant to 90 days post-implant procedure ] [ Designated as safety issue: No ]
    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).

  • Surgical Staff Utilized for Reveal In-office Implants [ Time Frame: At implant ] [ Designated as safety issue: No ]
    Observational analysis of surgical staff present at the Reveal Implants

  • Techniques and Procedures Utilized During Reveal In-office Implants [ Time Frame: At implant ] [ Designated as safety issue: No ]
    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.

  • Physician Satisfaction With Reveal In-office Implants [ Time Frame: At implant ] [ Designated as safety issue: No ]
    Observational survey of physicians satisfaction post implant At implant

  • R-wave Amplitude Measurement [ Time Frame: Implant procedure and 30 days post-implant procedure ] [ Designated as safety issue: No ]
    Average R-wave amplitude at implant and 30-days post procedure


Enrollment: 66
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168427

Locations
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 Disease Management
Investigators
Study Chair: Reveal In-Office Implants Clinical Research Specialist Medtronic
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01168427     History of Changes
Other Study ID Numbers: Reveal In-Office Implants
Study First Received: July 21, 2010
Results First Received: June 19, 2012
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014