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

Boston Scientific

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT00334451

CR-CA-030206-H

RAPID RF

Details and patient eligibility

About

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.

Enrollment: 891 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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