NCT02758301

Reveal LINQ™ Heart Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.

Detailed description

The study is a prospective, non-randomized, multi-center, observational, pre-market clinical study. The study is expected to be conducted at up to 30 centers in the United States. Up to 300 subjects will be enrolled to achieve approximately 40 heart failure events (no more than two per subject will contribute to the cumulative total). Study subjects will be followed for up to 3 years post-insertion or until official study closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, whichever occurs first. The expected study duration is approximately 4 years representing 1.5 years of enrollments and 2.5 years of follow-up. The LINQ™ HF study is a Non-Significant Risk Investigational Device Exemption (IDE) study. The study is utilizing the Reveal LINQ™ device with an investigational LINQ™ HF RAMware download.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Reveal LINQ™ Insertable Cardiac Monitor (ICM)	Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download

Timeline

• Start date: 2016-06-08
• Primary completion: 2018-12-04
• Completion: 2018-12-04
• First posted: 2016-05-02
• Last updated: 2019-11-12
• Results posted: 2019-11-12

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated device study