NCT00268320

Clinical Investigation of the Medtronic Concerto™ Device

Clinical Investigation of the Medtronic Concerto™ Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) Therapies (CRT+ICD Device)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (planned)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy may be prescribed. 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.

Conditions

• Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-06-01
• Completion: 2007-07-01
• First posted: 2005-12-22
• Last updated: 2008-09-25

Locations

51 sites across 12 countries: United States, Austria, Denmark, Germany, Greece, Italy, Japan, Netherlands, Norway, Spain, Switzerland, United Kingdom