Clinical trial NCT00334451: RAPID-RF: Remote Active Monitoring in Patients With Heart Failure
Official title: Remote Active Monitoring in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Remote Monitoring
Implantable Device
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-06-07
Enrollment: 891
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics, heart failure clinics, hospitals

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: University of Southern California
name: Leslie A Saxon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hershey Medical Center, Hershey, PA
name: John P Boehmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saxon LA, Boehmer JP, Neuman S, Mullin CM. Remote Active Monitoring in Patients with Heart Failure (RAPID-RF): design and rationale. J Card Fail. 2007 May;13(4):241-6. doi: 10.1016/j.cardfail.2006.12.004.