Physiological Response to Exercise: Sensor Evaluation at Specified Exertions (PRE-SENSE)

Boston Scientific

Status

Completed

Conditions

Heart Failure

Treatments

Device: SRD-1 conversion

Study type

Observational

Funder types

Industry

Identifiers

G100110 (Other Identifier)

PRE-SENSE

Details and patient eligibility

About

Assessment of sensor parameter in patients with heart failure.

Full description

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

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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