Study Stopped
Inappropriate therapy associated with certain right ventricular (RV) lead complications may occur more frequently if the Respiratory Sensor is programmed On
Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
CORRELATE-HF
CORRELATE-HF: Correlation Of Respiratory Rate Level And Trend Evaluation in Heart Failure Patients
1 other identifier
observational
56
2 countries
2
Brief Summary
The objective of the study is to determine if there is any relationship between respiratory rate and Heart Failure events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2008
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 23, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedNovember 6, 2009
November 1, 2009
11 months
September 19, 2008
November 4, 2009
Conditions
Study Arms (1)
Observation
Heart failure patients with an implanted CRT-D
Interventions
Eligibility Criteria
Heart failure patients with an implanted CRT-D.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
San Diego Cardiac Center
San Diego, California, 91213, United States
UZ Brussel
Brussels, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Jaski, MD
San Diego Cardiac Center
- PRINCIPAL INVESTIGATOR
Pedro Brugada, MD
Universitair Ziekenhuis Brussel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 23, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
November 6, 2009
Record last verified: 2009-11