Status:
COMPLETED
Clinical Investigation of the Medtronic Concerto™ Device
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the...
Eligibility Criteria
Inclusion
- Subjects who require the implantation of an Implantable Cardioverter Defibrillator
- 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
- Subjects who have constant atrial fibrillation (top chambers of the heart beat too fast continuously)
- Subjects who are post-heart transplant
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00268320
Start Date
January 1 2006
End Date
July 1 2007
Last Update
September 25 2008
Active Locations (51)
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1
Anchorage, Alaska, United States
2
Phoenix, Arizona, United States
3
Santa Monica, California, United States
4
Jacksonville, Florida, United States