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

This study has been completed.

Sponsored by: Boston Scientific Corporation
Information provided by: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00334451
  Purpose

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 Phase
Heart Failure
Phase IV

MedlinePlus related topics:   Heart Failure   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Remote Active Monitoring in Patients With Heart Failure

Further study details as provided by Boston Scientific Corporation:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   1000
Study Start Date:   May 2006
Study Completion Date:   July 2008
Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334451

Locations
United States, New York
Long Island Jewish Medical Center    
      New Hyde Park, New York, United States, 11040

Sponsors and Collaborators
Boston Scientific Corporation

Investigators
Principal Investigator:     Leslie A Saxon, MD     University of Southern California    
Principal Investigator:     John P Boehmer, MD     Hershey Medical Center, Hershey, PA    
  More Information


Publications indexed to this study:

Responsible Party:   Boston Scientific ( Steven McQuillan )
Study ID Numbers:   CR-CA-030206-H, RAPID RF
First Received:   June 5, 2006
Last Updated:   September 8, 2008
ClinicalTrials.gov Identifier:   NCT00334451
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 14, 2008




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