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

Completed

• Conditions: Heart Failure

• Registration Number: NCT00334451
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-05
• Study First Submitted QC: 2006-06-05
• Study First Posted: 2006-06-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-20
• Last Update Posted: 2014-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 891

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States