Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Reveal LINQ

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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

• Study Contact: Name: Priya Raman, Ph.D.; Phone Number: +1-763-505-9546; Email: priyadarshini.raman@medtronic.com

Study Locations

• United States
  • Florida
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology Associates
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center
    • Leesburg, Florida, United States, 34748
      • Clinical Site Partners Inc
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Virtua Pulmonology Marlton
  • New York
    • New York, New York, United States, 10075
      • Northwell Health Lenox Hill Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Cardiovascular Research Group
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The subject population for the LINQ for COPD study is COPD patients who are known to have frequent exacerbations (one requiring hospitalization, ED visit, or urgent care visit, or at least two others in the past year).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Christine Wendt, MD, U.S. Department of Veterans Affairs Minneapolis Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MDT19019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes