Heart Failure
Conditions
Brief summary
Assessment of sensor parameter in patients with heart failure.
Detailed description
Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.
Interventions
DEVICESRD-1 conversion
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COGNIS CRT-D model N119 or N120, functional bipolar leads: RA, RV, and LV lead all implanted for a minimum of 30 days * Prescribed to optimal pharmacologic therapy for heart failure for at least 30 days prior to enrollment * Age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
* Documented HF decompensation, as defined by a hospitalization or greater than a doubling of baseline diuretic dose due to worsening HF, within the last 3 months * Patients who are pacemaker dependent * Creatinine ≥ 2.5 mg/dL test within the last 3 months * Requires assistance walking, for example a cane or walker * Have an atrial tachyarrhythmia that is permanent or persistent * Have moderate to severe chronic pulmonary disease as defined by FEV1 \< 55% predicted * Documented life expectancy of less than 6 months * Patients at an unreasonable risk of not being able to reach the investigational center in case of an emergency, per physician discretion * Enrolled in any concurrent study
Countries
United States
Outcome results
None listed