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OpenTrials
Completed

NCT Number: NCT01168427

Reveal In-Office Implants

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reveal® DX or Reveal® XT Insertable Cardiac Monitor

Device

Reveal® DX and Reveal® XT Insertable Cardiac Monitors are implantable patient-activated and automatically-activated monitoring systems that record subcutaneous ECG.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Reveal® In-Office Implants Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 23, 2010
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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