Study of New Implantable Loop Recorder
Confirm Implantable Cardiac Monitor Study
1 other identifier
interventional
75
1 country
9
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2008
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 2, 2008
CompletedFirst Posted
Study publicly available on registry
September 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
April 30, 2015
CompletedJanuary 30, 2019
January 1, 2019
2.4 years
September 2, 2008
April 13, 2015
January 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (4)
Interpretability of Weekly Subject Activator Recordings
6 weeks
Interpretability of Automatically Triggered/Symptom Driven Recordings
6 weeks
Inappropriateness of Automatically Triggered Recordings - Phase I
6 weeks
- +1 more other outcomes
Study Arms (1)
Open Label
EXPERIMENTALSJM Confirm Device
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Alaska Heart Institute
Anchorage, Alaska, 99508, United States
Arizona Arrhythmia Research
Scottsdale, Arizona, 85251, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
St. Jude Hospital
Fullerton, California, 92835-2605, United States
Scripps Clinic
La Jolla, California, 92037, United States
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, 74104, United States
Providence- St Vincent Medical Center
Portland, Oregon, 97225, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
University of Virginia
Charlottesville, Virginia, 22980, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Studies
- Organization
- St. Jude Medical
Study Officials
- STUDY DIRECTOR
Tamara Shipman
Abbott Medical Devices
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2008
First Posted
September 4, 2008
Study Start
September 1, 2008
Primary Completion
February 1, 2011
Study Completion
June 1, 2014
Last Updated
January 30, 2019
Results First Posted
April 30, 2015
Record last verified: 2019-01