NCT04169529

Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	Reveal LINQ	Insertion of Reveal LINQ device to characterize collected data from patients with COPD.

Timeline

• Start date: 2020-08-25
• Primary completion: 2023-06-27
• Completion: 2023-06-27
• First posted: 2019-11-20
• Last updated: 2024-10-26
• Results posted: 2024-10-26

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study