Physiological Response to Exercise: Sensor Evaluation at Specified Exertions
NCT ID: NCT01229137
Last Updated: 2012-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
71 participants
OBSERVATIONAL
2011-06-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Right Ventricular Cohort
Right Ventricle wtih SRD-1 conversion
SRD-1 conversion
Left Ventricular Cohort
Left Ventricle with SRD-1 conversion
SRD-1 conversion
Right Atrium Cohart
Right atrium cohort with SRD-1 conversion
SRD-1 conversion
Interventions
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SRD-1 conversion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Bank, M.D.
Role: PRINCIPAL_INVESTIGATOR
United Heart and Vascular Center
Locations
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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
Countries
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Other Identifiers
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G100110
Identifier Type: OTHER
Identifier Source: secondary_id
PRE-SENSE
Identifier Type: -
Identifier Source: org_study_id