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Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation (ReSync AF)

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ClinicalTrials.gov Identifier: NCT00268294
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : December 18, 2008
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

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 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.

Condition or disease Intervention/treatment
Heart Failure, Atrial Arrhythmia Device: Cardiac Resynchronization Therapy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation
Study Start Date : May 2003
Primary Completion Date : April 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To compare the AF burden, frequency and duration of episodes when atrial therapies are ON vs. OFF.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268294

Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Principal Investigator: Burkhard Huegl, MD Zentralklinik Bad Berka GmbH

ClinicalTrials.gov Identifier: NCT00268294     History of Changes
Other Study ID Numbers: 221
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
cardiac resynchronization therapy, atrial arrhythmia

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes