Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices

Exclusion Criteria

• •Inability or refusal to sign the Subject Informed Consent
• •Inability of refusal to comply with the follow-up schedule
• •Documented as pacemaker dependent
• •Unable to rest comfortably in a semi-recumbent position for up to 20 minutes
• •Implanted with active Medtronic Fidelis lead models: 6930, 6931, 6948 or 6949
• •Currently implanted with unipolar RA, RV, or LV leads
• •LV sensitivity programmed to less than 0.7 mV AGC
• •History of appropriate tachycardia therapy (external or implanted) for rates \< 165 bpm within 1 week prior to enrollment
• •Device battery status indicates approximate time to explant \< 2 years
• •Likely to undergo lead or PG revision during the course of the study as determined by the investigator
• •Receiving regularly scheduled intravenous (IV) inotropic therapy as part of their drug regimen
• •Have received heart or lung transplant
• •Receiving mechanical circulatory support
• •Patients who have been referred or admitted for Hospice care
• •A life expectancy of less than 12 months per physician discretion
• •Enrolled in any concurrent study without Boston Scientific written approval
• •Devices previously converted to the SRD-1 and withdrawn from the study
• •Received a sub-pectoral COGNIS implant prior to February 1, 2011 with a dash number listed in Appendix K of the study protocol
• •Known pregnancy or plan to become pregnant within the course of the study
• •LV offset is programmed to a value greater than zero