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

This study has been terminated.
(Inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On)
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00758121
First received: September 19, 2008
Last updated: November 4, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention
Heart Failure
Device: Cardiac Resynchronization Therapy Defibrillator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CORRELATE-HF: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Enrollment: 56
Study Start Date: November 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observation
Heart failure patients with an implanted CRT-D
Device: Cardiac Resynchronization Therapy Defibrillator
CRT-D observational study

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758121

Locations
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
Principal Investigator: Brian Jaski, MD San Diego Cardiac Center
Principal Investigator: Pedro Brugada, MD UZ Brussel
  More Information

No publications provided

Responsible Party: Steve McQuillan / Director, Clinical Affairs, Boston Scientific CRM
ClinicalTrials.gov Identifier: NCT00758121     History of Changes
Other Study ID Numbers: CR-CA-091008-H
Study First Received: September 19, 2008
Last Updated: November 4, 2009
Health Authority: United States: Institutional Review Board
European Union: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014