Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients

Stopped early

Conditions studied: Heart Failure

In brief

The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.

Key facts

Study ID

NCT00758121

Run by

Boston Scientific Corporation

People needed

56

Starts

2008-11-01

Expected to finish

2009-10-01

Last updated by the study team

2009-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Diego Cardiac Center — San Diego, California, United States
• UZ Brussel — Brussels, Belgium

Full record on ClinicalTrials.gov

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