Study for Atrial Fibrillation Reduction (SAFARI)

This study has been completed.

First Received: December 19, 2005 Last Updated: May 19, 2006 History of Changes

Sponsored by:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00267137

Purpose

Atrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world’s most common kind of irregular heart beat.

People with AF experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness. Although AF can occur in otherwise healthy people for no apparent reason, it is sometimes associated with high blood pressure, heart disease or lung problems. The purpose of the SAFARI trial is to study the effectiveness of pacing algorithms in the upper chamber of the heart for patients who have both AF and bradycardia (slow heart beat).

Condition	Intervention
Atrial Fibrillation, Bradycardia	Device: Pacing Algorithms

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

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study for Atrial Fibrillation Reduction (SAFARI)

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

Primary Outcome Measures:

Safety/Efficacy

Secondary Outcome Measures:

Various

Estimated Enrollment:	540
Study Start Date:	September 2002

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with a slow heartbeat who are in need of dual chamber pacing (pacing in both the atrium and ventricle).
Subjects who have experienced at least two episodes of rapid heart beats three months prior to enrollment.

Exclusion Criteria:

Subjects who have a history of permanent (chronic) or persistent (non self-terminating) atrial fibrillation.
Subjects with atrial fibrillation due to reversible cause, (e.g. thyroid disease, pericarditis, post-surgery, alcohol abuse).
Subjects with a history of one or more cardioversions (changing an abnormal heart rhythm into a normal one by either using medication or by the application of an electric shock) six months prior to enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267137

Show 34 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Investigator:

Not Required For IDE Studies

More Information

Publications:

Gold MR, Hoffmann E; SAFARI Investigators. Rationale and design of a randomized clinical trial to assess the role of overdrive and triggered prevention pacing therapies in reducing atrial fibrillation: the Study of Atrial Fibrillation Reduction (SAFARI). Am Heart J. 2006 Aug;152(2):231-6.

Study ID Numbers:	190
Study First Received:	December 19, 2005
Last Updated:	May 19, 2006
ClinicalTrials.gov Identifier:	NCT00267137 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Pacemaker, Atrial Fibrillation/Therapy

Study placed in the following topic categories:

Heart Diseases
Bradycardia
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Bradycardia

Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009