Completed
Confirm Implantable Cardiac Monitor Study
What is being tested
SJM Confirm
Device
Who is being recruted
Cardiac Conduction System Disease+12
+ Arrhythmias, Cardiac
+ Atrial Fibrillation
Over 18 Years
+10 Eligibility Criteria
How is the trial designed
Diagnostic Study
Interventional
Study Start: September 2008
Summary
Principal SponsorAbbott Medical Devices
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2008
Actual date on which the first participant was enrolled.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).
Official TitleConfirm Implantable Cardiac Monitor Study
Principal SponsorAbbott Medical Devices
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
75 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiac Conduction System DiseaseArrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesConsciousness DisordersHeart DiseasesNervous System DiseasesNeurologic ManifestationsPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsSyncopeTachycardiaUnconsciousnessNeurobehavioral Manifestations
Criteria
5 inclusion criteria required to participate
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
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5 exclusion criteria prevent from participating
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSJM Confirm Device
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Suspended
Suspended
Arizona Arrhythmia Research
Scottsdale, United StatesSuspended
Arkansas Heart Hospital
Little Rock, United StatesSuspended
St. Jude Hospital
Fullerton, United StatesCompleted9 Study Centers