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OpenTrials
Completed

NCT Number: NCT00268294

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zentralklinik Bad Berka GmbH

Bad Berka, 99437, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac resynchronization therapy

Device

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Dec 22, 2005
Registry last updated
Dec 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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