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OpenTrials
Completed

NCT Number: NCT00746564

Study of New Implantable Loop Recorder

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).

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Key information

Conditions

Tachyarrhythmias Arrhythmias, Cardiac Atrial Fibrillation Cardiac Conduction System Disease Cardiovascular Diseases Consciousness Disorders Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Syncope Tachycardia Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alaska Heart Institute, Anchorage, Alaska, 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

  • 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

Treatment and study plan

SJM Confirm

Device

All patients in this study will receive the SJM Confirm device.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Confirm Implantable Cardiac Monitor Study

Important dates

Study start
2008
Primary completion
2011
Study completion
2014
First posted
Sep 4, 2008
Registry last updated
Jan 30, 2019

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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