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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00268294
First received: December 21, 2005
Last updated: December 16, 2008
Last verified: December 2008
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
cardiac resynchronization therapy, atrial arrhythmia

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

ClinicalTrials.gov processed this record on July 24, 2014