Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
- Conditions
- Heart Failure
- Registration Number
- NCT01229137
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Cardiovascular Associates of Northeast Arkansas
🇺🇸Jonesboro, Arkansas, United States
Regional Cardiology Consultants
🇺🇸Sacremento, California, United States
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Heart and Vascular Institute of Florida
🇺🇸Clearwater, Florida, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
St. John's Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
United Heart and Vascular Clinic
🇺🇸St. Paul, Minnesota, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Cardiovascular Research Institure, LLC
🇺🇸Canton, Ohio, United States
Scroll for more (4 remaining)Cardiovascular Associates of Northeast Arkansas🇺🇸Jonesboro, Arkansas, United States