Atrial Fibrillation Clinical Trial
— ALERT-AFOfficial title:
The Comparative Efficacy of the Zio Patch vs Implantable Loop Recorder in Atrial Fibrillation
Verified date | March 2017 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of our study is to investigate if LTCM's are superior to implantable loop recorders in detecting atrial fibrillation after pulmonary vein isolation. This study will provide insights on a possible alternative for detection of arrhythmia.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with a diagnosis of paroxysmal or persistent atrial fibrillation documented on electrocardiography 2. Patients must already have a Medtronic LINQ ILR as standard of care already implanted as standard of care 3. Patients must be available for at least 7 but maximum of 14 days after patch application 4. Patients must be greater than or equal to 18 years old. Exclusion Criteria: 1. Patients with a history of permanent atrial fibrillation 2. Patients with an implanted pacemaker or implantable cardioverter defibrillator 3. Patients with cognitive delay and or dementia 4. Patients unable to give Consent. 5. Patients with adhesive allergy |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement between the assessment of events between the two devices | 10 days | ||
Secondary | Sensitivity, Specificity, PPV, Accuracy and Reliability | the ECG from the LCTM will be used as the gold standard to assess the LCTM events and the ECG from the ILR will be used to assess the ILR events. | 10 days | |
Secondary | Signal quality | Measured in Voltage from baseline | 10 days |
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