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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 5, 2006
First Posted Date June 7, 2006
Last Update Posted Date February 24, 2014
Study Start Date May 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00334451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title RAPID-RF: Remote Active Monitoring in Patients With Heart Failure
Official Title Remote Active Monitoring in Patients With Heart Failure
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care clinics, heart failure clinics, hospitals
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 20, 2014)
891
Original Enrollment
 (submitted: June 5, 2006)
1000
Actual Study Completion Date July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00334451
Other Study ID Numbers CR-CA-030206-H
RAPID RF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor Boston Scientific Corporation
Collaborators Not Provided
Investigators
Principal Investigator: Leslie A Saxon, MD University of Southern California
Principal Investigator: John P Boehmer, MD Hershey Medical Center, Hershey, PA
PRS Account Boston Scientific Corporation
Verification Date February 2014