Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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The purpose of the LINQ™ for COPD study is to characterize Reveal LINQ™ derived data from patients with COPD by assessing the relationship between changes in LINQ™ derived data with COPD exacerbation events.

Detailed Description
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Chronic Obstructive Pulmonary Disease (COPD) is progressive and currently incurable and refers to a collection of diseases that lead to the key feature of irreversible airflow limitation and breathing related problems. Of those with COPD, 46% experienced at least one exacerbation within the previous year and 19% needed hospitalization. The financial burden of COPD is also evident, in that over $32 billion was spent for COPD care in the United States in 2010 and it is expected to be close to $50 billion in 2020. Reducing healthcare utilization associated with COPD patient management (i.e. short-term readmission and chronic disease management) is a critically important unmet need for patients, caregivers, and hospitals. Early detection, prevention, and treatment of COPD exacerbation would aim to reduce this high morbidity and cost. To help reduce these exacerbations and improve disease management, sensors in a minimally invasive device can be used to identify factors that are associated with exacerbations.

Official Title
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Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: Reveal LINQ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 45 years old Patient (or patient's legally authorized representative) is willing and able to provide written informed consent Patient is willing and able to comply with the protocol, including follow-up visits, electronic diary submissions and CareLink transmissions FEV1 (post bronchodilator) ≤ 70% of predicted Current or former smoker with lifetime cigarette consumption of > 10 pack-years One COPD exacerbation in the previous 12 months requiring hospitalization, urgent care or emergency department visit for respiratory illness OR Two COPD exacerbations within the previous 12 months requiring antibiotics and/or corticosteroids for respiratory symptoms. The patient's medical records must be accessible by the enrolling site over the follow-up period Exclusion Criteria: Less than 30 days from diagnosis of a COPD exacerbation as defined as taking antibiotics and/or corticosteroids for respiratory symptoms, hospitalization, urgent care or emergency department visit for respiratory illness. Less than 30 days from diagnosis of a HF event as defined as any cardiovascular-related (including hypervolemia) Health Care Utilizations (HCUs) for any one of the following events: Admission with primary diagnosis of HF Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: Admission with secondary/tertiary diagnosis of HF Emergency Department Ambulance Observation Unit Urgent Care HF/Cardiology Clinic Active respiratory infection being treated with antibiotics and/or corticosteroids Class IV heart failure Clinical diagnosis of unstable angina, bronchiectasis, or cystic fibrosis Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment) Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager Patient has an existing or planned implantation of Medtronic IPG, ICD, CRT-D or CRT-P device in the near future Patient has an existing and active insertable cardiac monitor, regardless of manufacturer Concurrent disease with life expectancy less than 1 year

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Reveal LINQ|Insertion of Reveal LINQ device to characterize collected data from patients with COPD.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reveal LINQ™ derived data in patients with COPD | Characterizing LINQ derived data with COPD events | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD