Heart Failure
Conditions
Keywords
Heart Failure, Remote Monitoring, Implantable Device
Brief summary
The RAPID-RF Registry aims to characterize LATITUDE® Patient Management's alert feature: LATITUDE Active Monitoring™ by evaluating type and frequency of alert notifications and alert-related medical interventions. This registry will also assess clinical outcomes including quality of life and New York Heart Association Class changes over time, mortality, hospitalizations and heart failure-related event rates.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed