Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

Completed

Conditions studied: Heart Failure

In brief

Assessment of sensor parameter in patients with heart failure.

Key facts

Study ID

NCT01229137

Run by

Boston Scientific Corporation

People needed

71

Starts

2011-06-01

Expected to finish

2012-08-01

Last updated by the study team

2012-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — Saint Paul, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Cardiovascular Research Institure, LLC — Canton, Ohio, United States
• Texas Cardiac Arrhythmia Research — Austin, Texas, United States
• Tyler Cardiovascular Associates — Tyler, Texas, United States
• Thomas Bunch — Murray, Utah, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.