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Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients (CORRELATE-HF)

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: NCT00758121
Recruitment Status : Terminated (Inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On)
First Posted : September 23, 2008
Last Update Posted : November 6, 2009
Sponsor:
Information provided by:
Boston Scientific Corporation

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

Condition or disease Intervention/treatment
Heart Failure Device: Cardiac Resynchronization Therapy Defibrillator

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 as other diagnostic features, including but not limited to, activity level, heart rate, and lead impedance.
Study Design
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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CORRELATE-HF: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
Study Start Date : November 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
Observation
Heart failure patients with an implanted CRT-D
 Device: Cardiac Resynchronization Therapy Defibrillator
CRT-D observational study


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patients with an implanted CRT-D.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758121


Locations
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United States, California
San Diego Cardiac Center
San Diego, California, United States, 91213
Belgium
UZ Brussel
Brussels, Belgium
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Brian Jaski, MD San Diego Cardiac Center
Principal Investigator: Pedro Brugada, MD Universitair Ziekenhuis Brussel
More Information
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Responsible Party: Steve McQuillan / Director, Clinical Affairs, Boston Scientific CRM
ClinicalTrials.gov Identifier: NCT00758121    
Other Study ID Numbers: CR-CA-091008-H
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases