Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure

Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization

This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).

Inclusion Criteria:

• Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device
• Patient consents to study
• Ability to replace follow-ups with CareLink follow-ups
• Ability to attend all follow-ups at study center

Exclusion Criteria:

• Permanent AF
• Less than 18 years of age
• Life expectancy less than 15 months
• Participation in another clinical study
• Pregnancy