Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT04169529

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2023-06-27

Brief 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.

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Reveal LINQ

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Wendt, MD

Role: PRINCIPAL_INVESTIGATOR

U.S. Department of Veterans Affairs Minneapolis Healthcare System

Locations

Bay Area Cardiology Associates

Brandon, Florida, United States

Baptist Medical Center

Jacksonville, Florida, United States

Clinical Site Partners Inc

Leesburg, Florida, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Virtua Pulmonology Marlton

Marlton, New Jersey, United States

Northwell Health Lenox Hill Hospital

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MDT19019

Identifier Type: -

Identifier Source: org_study_id