NCT01216670

Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Medtronic Italia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a short term and a long term period, incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation.

Detailed description

The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial designed in two phases. The purpose of the study is to assess a short term (6 months follow-up - Phase 1) and a long term period (24 months follow-up - Phase 2), incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation. A previously implanted Reveal® XT device will be used to collect heart rhythm information.

Conditions

• Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	remote patient's management	scheduled remote CareLink data transmission

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-11-01
• Completion: 2014-05-01
• First posted: 2010-10-07
• Last updated: 2015-10-14

Locations

4 sites across 1 country: Italy