Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

Boston Scientific Corporation14 sites in 1 country71 target enrollmentJune 2011

Overview

Assessment of sensor parameter in patients with heart failure.

Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

August 2012

Last Updated

13 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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