Clinical trial NCT00746564: Study of New Implantable Loop Recorder
Official title: Confirm Implantable Cardiac Monitor Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachyarrhythmias
Syncope
Keywords: Implantable Cardiac Monitor
Arrhythmias
Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility 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 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

Primary outcomes:
measure: Sensitivity for R Waves During In-Clinic Recordings at Rest
timeFrame: 6 weeks
measure: Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise
timeFrame: 6 weeks
measure: Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers
timeFrame: 6 weeks
measure: Positive Predictive Value (PPV) for In-Clinic Recordings at Rest
timeFrame: 6 weeks
measure: Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test
timeFrame: 6 weeks
measure: Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
measure: Interpretability of Weekly Subject Activator Recordings
timeFrame: 6 weeks
measure: Interpretability of Automatically Triggered/Symptom Driven Recordings
timeFrame: 6 weeks
measure: Inappropriateness of Automatically Triggered Recordings - Phase I
timeFrame: 6 weeks
measure: Inappropriateness of Automatically Triggered Recordings - Phase II
timeFrame: 6 weeks
Locations:
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Research
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Fullerton
country: United States
facility: St. Jude Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Tulsa
country: United States
facility: Oklahoma Heart Institute at Utica
state: Oklahoma
city: Portland
country: United States
facility: Providence- St Vincent Medical Center
state: Oregon
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Abbott Medical Devices
name: Tamara Shipman
role: STUDY_DIRECTOR
References: