Heart Failure, Atrial Arrhythmia Clinical Trial
Official title:
Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation
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 characterize the impact of cardiac resynchronization therapy
versus cardiac resynchronization therapy with atrial therapies on the incidence, duration
and termination of atrial tachyarrhythmias.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | April 2006 |
| Est. primary completion date | April 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects with atrial fibrillation - Subjects with a heart beat that is too fast and who have been determined by a doctor to require an implantable cardioverter defibrillator (ICD) i. Exclusion Criteria: - Subjects with a natural heart rate less than 30bpm |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Zentralklinik Bad Berka GmbH | Bad Berka |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Cardiac Rhythm Disease Management | Medtronic |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To compare the AF burden, frequency and duration of episodes when atrial therapies are ON vs. OFF. |