Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)

NCT04169529 | Completed Results FDA Device

• 1 other identifier: MDT19019
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 9

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• COPD Event

  Incidence of first COPD event

  from subject randomization until 12 month follow-up

Interventions

Reveal LINQ DEVICE

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (9)

Bay Area Cardiology Associates

Brandon, Florida, 33511, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

Clinical Site Partners Inc

Leesburg, Florida, 34748, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Virtua Pulmonology Marlton

Marlton, New Jersey, 08053, United States

Location

Northwell Health Lenox Hill Hospital

New York, New York, 10075, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Andy St. Martin
• Organization: Medtronic

andy.stmartin@medtronic.com

(952) 220-4009

Study Officials

• Christine Wendt, MD

  U.S. Department of Veterans Affairs Minneapolis Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: August 25, 2020
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: October 26, 2024
• Results First Posted: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)