Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00279955
First received: January 18, 2006
Last updated: June 11, 2012
Last verified: June 2012
Results First Received: July 20, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Heart Failure, Congestive
Intervention: Device: Cardiac Resynchronization Therapy Device

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
1024 subjects were enrolled in the study from 21 JUN 2004 through 14 FEB 2007 from 100 centers in US. Follow-up data collection ended on 06 MAR 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
23 of 1024 subjects exited prior to successful implant due to not meeting in/exclusion criteria, unsucessful implants, missing informed consent form etc. Of the remaining 1001 subjects, 643 subjects had been followed longer than 6 months and had the OptiVol feature save-to-disk data available. Those 643 subjects were used for analyzing objectives.

Reporting Groups
  Description
At Least 1 OptiVol Fluid Index > 100 During DREP All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
No OptiVol Fluid Index > 100 During DREP All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
No OptiVol Measurement All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.

Participant Flow:   Overall Study
    At Least 1 OptiVol Fluid Index > 100 During DREP     No OptiVol Fluid Index > 100 During DREP     No OptiVol Measurement  
STARTED     157     486     358  
COMPLETED     157     486     358 [1]
NOT COMPLETED     0     0     0  
[1] They are still counted as completes, though they are never used for the analyses of objectives.



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Occurrence of Heart Failure (HF) Related Adverse Event (AE)   [ Time Frame: From 6 month to the 12 month visit ]

2.  Secondary:   Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)   [ Time Frame: 6 month to the 12 month visit ]

3.  Secondary:   Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)   [ Time Frame: 6 month to the 12 month visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information