NCT Number: NCT01229137
Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
Assessment of sensor parameter in patients with heart failure.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Cardiovascular Associates of Northeast Arkansas, Jonesboro, Arkansas, United States
About this study
Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Boston Scientific Corporation
Industry
Registry information
Acronym: PRE-SENSE
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 27, 2010
- Registry last updated
- Sep 12, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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