Clinical trial NCT01229137: Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
Official title: Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients with an implanted CRT-D

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Cardiovascular Associates of Northeast Arkansas
state: Arkansas
city: Sacremento
country: United States
facility: Regional Cardiology Consultants
state: California
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Heart and Vascular Institute of Florida
state: Florida
city: Davenport
country: United States
facility: Genesis Medical Center
state: Iowa
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: St. John's Hospital and Medical Center
state: Michigan
city: St. Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Canton
country: United States
facility: Cardiovascular Research Institure, LLC
state: Ohio
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiovascular Associates
state: Texas
city: Murray
country: United States
facility: Thomas Bunch
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: United Heart and Vascular Center
name: Alan Bank, M.D.
role: PRINCIPAL_INVESTIGATOR
References: