Long-term assessment of heart failure monitoring system

Long-term assessment of heart failure monitoring system - Continued Access

Full Name

Heart Failure (CM-10-01): CHAMPION CardioMEMS heart sensor allows monitoring of pressure to improve outcomes in NYHA class III heart failure patients (1_PRO00000090)

Description

This prospective, multi-center, open-label clinical trial is only for participants who completed their three year follow-up visit in the prior CHAMPION trial. After signing a new consent, participants will be followed for an additional two years, and will take daily pressure readings using the Champion HF Monitoring System. Study visits for physical examination will be scheduled every 6 months during the study period.

Eligibility

Inclusion Criteria

Previous enrollment in the CHAMPION trial, and having completed the three year follow-up visit
Negative pregnancy test at enrollment visit, and agreement to use a reliable form of contraception for the study duration
Clinical condition sufficient to enable participant to complete the study