RAPID-RF: Remote Active Monitoring in Patients With Heart Failure

Primary care clinics, heart failure clinics, hospitals

Inclusion Criteria:

• Patients who meet current indications for a Guidant RF-enabled CRT-D device (e.g. CONTAK RENEWAL 3 RF family of CRT-D devices) which is compatible with the LATITUDE Communicator. Indications include: NYHA Class III, IV; EF of ≤ 35%; QRS duration of ≥ 120 ms; and optimized pharmacologic therapy
• Patients who have an analog telephone line compatible with the LATITUDE Communicator. The LATITUDE Communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.
• Patients who receive the study components including the LATITUDE Communicator, weight scale, and blood pressure monitor
• Patients who are willing and capable of providing informed consent prior to implant and willing to participate in the RAPID-RF Registry
• Patients who remain in the clinical care of a RAPID-RF investigator at approved centers

Exclusion Criteria:

• Patients who are expected to receive a heart transplant during the course of the study
• Patients who have received or who will receive a tricuspid valve prosthesis during the course of the study
• Patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular ICD)
• Patients whose life expectancy is less than 12 months
• Patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the RAPID-RF Registry. Contact Guidant's Clinical Application Research Study (CARS) department to determine eligibility.
• Patients who are younger than 18 years of age
• Patients who are pregnant or plan to become pregnant during the study
• Patients who are unable or refuse to comply with the protocol requirements