NCT01486316

Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.

Conditions

• Atrial Fibrillation
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Reveal XT® Insertable Cardiac Monitor	If not previously implanted, a non-experimental insertable cardiac monitor will be implanted to collect information on the patients' heart condition as inputs into the heart failure risk status algorithm (during guided follow-up only, Guided arm: 6-18 months, Control arm: 12-18 months).
OTHER	Heart Failure Risk Status Diagnostic	The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status and standard device trend data are provided to study doctors for remote management of their patients' heart failure using study specific protocols. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High".

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-12-01
• Completion: 2015-02-01
• First posted: 2011-12-06
• Last updated: 2018-07-12
• Results posted: 2018-07-12

Locations

11 sites across 1 country: United States