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

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ClinicalTrials.gov Identifier: NCT00334451
Recruitment Status : Completed
First Posted : June 7, 2006
Last Update Posted : February 24, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Heart Failure

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Study Type : Observational
Actual Enrollment : 891 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remote Active Monitoring in Patients With Heart Failure
Study Start Date : May 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinics, heart failure clinics, hospitals
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334451


Locations
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United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Leslie A Saxon, MD University of Southern California
Principal Investigator: John P Boehmer, MD Hershey Medical Center, Hershey, PA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00334451     History of Changes
Other Study ID Numbers: CR-CA-030206-H
RAPID RF
First Posted: June 7, 2006    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014

Keywords provided by Boston Scientific Corporation:
Heart Failure
Remote Monitoring
Implantable Device

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases