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: April 13, 2015
Last verified: April 2015
  Purpose

The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the SJM Confirm Implantable Cardiac Monitor (device).


Condition Intervention
Tachyarrhythmias
Syncope
Device: SJM Confirm

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Confirm Implantable Cardiac Monitor Study

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 PA recording and for each subject. A random effects model was fitted to the data.

  • InInterpretability 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 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.


Enrollment: 75
Study Start Date: September 2008
Study Completion Date: June 2014
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label Device: SJM Confirm
All patients in this study will receive the SJM Confirm device.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  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: NCT00746564

Locations
United States, Alaska
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
United States, Arizona
Arizona Arrhythmia Research
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
St. Jude Hospital
Fullerton, California, United States, 92835-2605
Scripps Clinic
La Jolla, California, United States, 92037
United States, Oklahoma
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Providence- St Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22980
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Tamara Shipman St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00746564     History of Changes
Other Study ID Numbers: 60020941D
Study First Received: September 2, 2008
Results First Received: April 13, 2015
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
Implantable Cardiac Monitor
Arrhythmias
Atrial Fibrillation

ClinicalTrials.gov processed this record on September 01, 2015