Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation (ReSync AF) - Full Text View

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00268294

Purpose

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	Intervention
Heart Failure, Atrial Arrhythmia	Device: Cardiac Resynchronization Therapy

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

To compare the AF burden, frequency and duration of episodes when atrial therapies are ON vs. OFF.

Estimated Enrollment:	20
Study Start Date:	May 2003
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268294

Locations

Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Medtronic

Investigators

Principal Investigator:

Burkhard Huegl, MD

Zentralklinik Bad Berka GmbH

More Information

No publications provided

Study ID Numbers:	221
Study First Received:	December 21, 2005
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00268294 History of Changes
Health Authority:	Germany-Competent Authority: Bezirksregierung Dusseldorf

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

cardiac resynchronization therapy, atrial arrhythmia

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Atrial Premature Complexes

Atrial Fibrillation
Cardiac Complexes, Premature
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Heart Failure
Pathologic Processes
Heart Diseases
Atrial Premature Complexes

Cardiovascular Diseases
Atrial Fibrillation
Cardiac Complexes, Premature
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 10, 2009