Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169529
• Other study ID #: MDT19019
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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