Heart Failure
Conditions
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 as other diagnostic features, including but not limited to, activity level, heart rate, and lead impedance.
Interventions
CRT-D observational study
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
Belgium, United States
Outcome results
None listed