Study of New Implantable Loop Recorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00746564
First received: September 2, 2008
Last updated: November 1, 2015
Last verified: November 2015

September 2, 2008
November 1, 2015
September 2008
February 2011   (final data collection date for primary outcome measure)
  • Sensitivity for R Waves During In-Clinic Recordings at Rest [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.
Not Provided
Complete list of historical versions of study NCT00746564 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Interpretability of Weekly Subject Activator Recordings [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
 
Study of New Implantable Loop Recorder
Confirm Implantable Cardiac Monitor Study
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).
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Tachyarrhythmias
  • Syncope
Device: SJM Confirm
All patients in this study will receive the SJM Confirm device.
Experimental: Open Label
SJM Confirm Device
Intervention: Device: SJM Confirm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
June 2014
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00746564
60020941D
No
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Study Director: Tamara Shipman St. Jude Medical
St. Jude Medical
November 2015

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