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

NCT ID: NCT00268294

Last Updated: 2008-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure, Atrial Arrhythmia

Keywords

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cardiac resynchronization therapy, atrial arrhythmia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cardiac Resynchronization Therapy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Principal Investigators

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Burkhard Huegl, MD

Role: PRINCIPAL_INVESTIGATOR

Zentralklinik Bad Berka GmbH

Locations

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Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Site Status

Countries

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Germany

Other Identifiers

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221

Identifier Type: -

Identifier Source: org_study_id