Status:
COMPLETED
Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01229137
Start Date
June 1 2011
End Date
August 1 2012
Last Update
September 12 2012
Active Locations (14)
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1
Cardiovascular Associates of Northeast Arkansas
Jonesboro, Arkansas, United States, 72401
2
Regional Cardiology Consultants
Sacremento, California, United States, 95819
3
Danbury Hospital
Danbury, Connecticut, United States, 06810
4
Heart and Vascular Institute of Florida
Clearwater, Florida, United States, 33756