Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation Clinical Trial
Official title:
Clinical Investigation of the Medtronic Concerto™ Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) Therapies (CRT+ICD Device)
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment