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).

Study Overview

• Status: Completed
• Conditions: Syncope; Tachyarrhythmias
• Intervention / Treatment: Device: SJM Confirm

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label; SJM Confirm Device	Device: SJM Confirm; All patients in this study will receive the SJM Confirm device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for R Waves During In-Clinic Recordings at Rest	The sensitivity was calculated for each recording and for each subject.	6 weeks
Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise	The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.	6 weeks
Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers	The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.	6 weeks
Positive Predictive Value (PPV) for In-Clinic Recordings at Rest	The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.	6 weeks
Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test	The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.	6 weeks
Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers	The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interpretability of Weekly Subject Activator Recordings	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.	6 weeks
Interpretability of Automatically Triggered/Symptom Driven Recordings	The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.	6 weeks
Inappropriateness of Automatically Triggered Recordings - Phase I	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.	6 weeks
Inappropriateness of Automatically Triggered Recordings - Phase II	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.	6 weeks

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Tamara Shipman, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 2, 2008
• First Submitted That Met QC Criteria: September 3, 2008
• First Posted (Estimate): September 4, 2008

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Implantable Cardiac Monitor; Arrhythmias
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Tachycardia; Syncope
• Other Study ID Numbers: 60020941D