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

Primary Purpose

Heart Failure, Atrial Arrhythmia

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Cardiac Resynchronization Therapy

About this trial

This is an interventional treatment trial for Heart Failure, Atrial Arrhythmia focused on measuring cardiac resynchronization therapy, atrial arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zentralklinik Bad Berka GmbH

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00268294

First Posted

December 21, 2005

Last Updated

December 16, 2008

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT00268294

Brief Title

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

Official Title

Restoring Sinus Rhythm With Cardiac Resynchronization in Patients With Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Atrial Arrhythmia

Keywords

cardiac resynchronization therapy, atrial arrhythmia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Cardiac Resynchronization Therapy

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Burkhard Huegl, MD

Organizational Affiliation

Zentralklinik Bad Berka GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zentralklinik Bad Berka GmbH

City

Bad Berka

ZIP/Postal Code

99437

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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