Status:
COMPLETED
RAPID-RF: Remote Active Monitoring in Patients With Heart Failure
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
891 Patients enrolled
Trial Details
Trial ID
NCT00334451
Start Date
May 1 2006
End Date
July 1 2008
Last Update
February 24 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040