Status:
TERMINATED
Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.
Detailed Description
The purpose of the CORRELATE-HF study is to collect RRT data in heart failure patients to gain a better understanding of how respiratory rate changes in relation to all cause clinical events as well a...
Eligibility Criteria
Inclusion
- Implanted COGNIS device or future commercially available Boston Scientific CRT-D, that contains the Sensor Trend for Respiratory Rate, with a right ventricular lead and left ventricular lead actively implanted
- Respiratory Sensor programmed "On"
- Classified as having NYHA Class III heart failure documented, in the past 12 months
- Age 18 or above, or of legal age to give informed consent specific to state and national law
- Willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
Exclusion
- Inability or refusal to sign the patient Informed Consent
- Inability or refusal to comply with the follow-up schedule
- Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
- Patients prescribed to positive airway pressure therapy
- A life expectancy of less than 180 days, per physician discretion
- Enrolled in any concurrent study without prior written approval from Boston Scientific CRM
- Women who are pregnant or plan to become pregnant in the next twelve months
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00758121
Start Date
November 1 2008
End Date
October 1 2009
Last Update
November 6 2009
Active Locations (2)
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1
San Diego Cardiac Center
San Diego, California, United States, 91213
2
UZ Brussel
Brussels, Belgium