Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of New Implantable Loop Recorder

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.
 
ClinicalTrials.gov Identifier: NCT00746564
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : April 30, 2015
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE September 2, 2008
First Posted Date  ICMJE September 4, 2008
Results First Submitted Date  ICMJE April 13, 2015
Results First Posted Date  ICMJE April 30, 2015
Last Update Posted Date January 30, 2019
Study Start Date  ICMJE September 2008
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
  • Sensitivity for R Waves During In-Clinic Recordings at Rest [ Time Frame: 6 weeks ]
    The sensitivity was calculated for each recording and for each subject.
  • Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise [ Time Frame: 6 weeks ]
    The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
  • Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers [ Time Frame: 6 weeks ]
    The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
  • Positive Predictive Value (PPV) for In-Clinic Recordings at Rest [ Time Frame: 6 weeks ]
    The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
  • Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test [ Time Frame: 6 weeks ]
    The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
  • Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers [ Time Frame: 6 weeks ]
    The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2015)
  • Interpretability of Weekly Subject Activator Recordings [ Time Frame: 6 weeks ]
    The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject. A random effects model was fitted to the data.
  • Interpretability of Automatically Triggered/Symptom Driven Recordings [ Time Frame: 6 weeks ]
    The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.
  • Inappropriateness of Automatically Triggered Recordings - Phase I [ Time Frame: 6 weeks ]
    The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a generalized estimating equation (GEE) model for binomial outcomes to account for multiple recordings per patient.
  • Inappropriateness of Automatically Triggered Recordings - Phase II [ Time Frame: 6 weeks ]
    The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a GEE model for binomial outcomes to account for multiple recordings per patient.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of New Implantable Loop Recorder
Official Title  ICMJE Confirm Implantable Cardiac Monitor Study
Brief Summary The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Tachyarrhythmias
  • Syncope
Intervention  ICMJE Device: SJM Confirm
All patients in this study will receive the SJM Confirm device.
Study Arms  ICMJE Experimental: Open Label
SJM Confirm Device
Intervention: Device: SJM Confirm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2012)
75
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias
  • Patients who experience transient symptoms that may suggest a cardiac arrhythmia
  • Patients who have been previously diagnosed with atrial fibrillation
  • Patients who are suspected to have Atrial Fibrillation (AF) but AF has not been documented
  • Patients who have provided written informed consent to participate in the study.

Exclusion Criteria:

  • Patients who are under the age of 18 years
  • Patients who have a life expectancy less than 1 year
  • Patients who are unable to comply with the follow-up schedule
  • Patients who are currently implanted with a pacemaker or defibrillator
  • Patients who the physician deems inappropriate for the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00746564
Other Study ID Numbers  ICMJE 60020941D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tamara Shipman Abbott Medical Devices
PRS Account Abbott Medical Devices
Verification Date January 2019

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