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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04169529
Other study ID # MDT19019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 25, 2020
Est. completion date June 27, 2023

Study information

Verified date October 2023
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date June 27, 2023
Est. primary completion date June 27, 2023
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Reveal LINQ
Insertion of Reveal LINQ device to characterize collected data from patients with COPD.

Locations

Country Name City State
United States Bay Area Cardiology Associates Brandon Florida
United States The Ohio State University Columbus Ohio
United States Baptist Medical Center Jacksonville Florida
United States Lancaster General Hospital Lancaster Pennsylvania
United States Clinical Site Partners Inc Leesburg Florida
United States Virtua Pulmonology Marlton Marlton New Jersey
United States Northwell Health Lenox Hill Hospital New York New York
United States Oklahoma Cardiovascular Research Group Oklahoma City Oklahoma
United States Memorial Health University Medical Center Savannah Georgia

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reveal LINQ™ derived data in patients with COPD Characterizing LINQ derived data with COPD events 24 months
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