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

July 21, 2010
August 27, 2012
August 2010
May 2011   (final data collection date for primary outcome measure)
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.
Procedure-related complications requiring resolution by surgical intervention [ Time Frame: From Implant to 90 days post-implant procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01168427 on ClinicalTrials.gov Archive Site
  • 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
  • Rate of procedure-related adverse events [ Time Frame: From Implant to 90 days post-implant procedure ] [ Designated as safety issue: No ]
  • Surgical staff utilized for Reveal in-office implants [ Time Frame: At implant ] [ Designated as safety issue: No ]
  • Techniques and procedures utilized during Reveal in-office implants [ Time Frame: At implant ] [ Designated as safety issue: No ]
  • Physician satisfaction with Reveal in-office implants [ Time Frame: At implant ] [ Designated as safety issue: No ]
  • R-wave amplitude measurement [ Time Frame: Implant procedure and 30 days post-implant procedure ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Reveal In-Office Implants
Reveal® In-Office Implants Study

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Arrhythmias, Cardiac
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01168427
Reveal In-Office Implants
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Study Chair: Reveal In-Office Implants Clinical Research Specialist Medtronic
Medtronic Cardiac Rhythm Disease Management
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP