Clinical Investigation of the Medtronic Concerto™ Device
NCT ID: NCT00268320
Last Updated: 2008-09-25
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
NA
270 participants
INTERVENTIONAL
2006-01-31
2007-07-31
Brief Summary
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People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD).
Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.
The purpose of this study is to study an investigational implantable device containing Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) therapies (CRT+ICD device) in subjects who are at significant risk of developing atrial tachyarrhythmias.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
Eligibility Criteria
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Inclusion Criteria
* Subjects who have heart failure that severely limits daily activities (NYHA Class III) or Subjects who have severe heart failure and should always be resting (NYHA Class IV)
* Subjects with reduced heart pumping function (left ventricular ejection fraction ≤ 35%)
Exclusion Criteria
* Subjects who are post-heart transplant
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Principal Investigators
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Not required for IDE studies
Role:
Locations
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Anchorage, Alaska, United States
Phoenix, Arizona, United States
Santa Monica, California, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Atlanta, Georgia, United States
Evanston, Illinois, United States
Fort Wayne, Indiana, United States
Des Moines, Iowa, United States
Brighton, Massachusetts, United States
Detroit, Michigan, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
Albuquerque, New Mexico, United States
Syracuse, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
West Reading, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Richmond, Virginia, United States
Tacoma, Washington, United States
Morgantown, West Virginia, United States
Linz, , Austria
Sankt Pölten, , Austria
Copenhagen, , Denmark
Aachen, , Germany
Bernau, , Germany
Bochum, , Germany
Göttingen, , Germany
Heidelberg, , Germany
Münster, , Germany
Pátrai, , Greece
Negrar, Veneto, Italy
Bologna, , Italy
Tsukuba, Ibaraki, Japan
Suita, Osaka, Japan
Shinjuku-ku, Tokyo, Japan
Eindhoven, , Netherlands
Rotterdam, , Netherlands
Oslo, , Norway
Valencia, , Spain
Basel, , Switzerland
Southhampton, , United Kingdom
Countries
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Other Identifiers
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230
Identifier Type: -
Identifier Source: org_study_id