Study for Atrial Fibrillation Reduction (SAFARI)

This study has been completed.

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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Study for Atrial Fibrillation Reduction (SAFARI)

Resource links provided by NLM:

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

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

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.

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

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Pacemaker, Atrial Fibrillation/Therapy

Additional relevant MeSH terms:

Atrial Fibrillation
Bradycardia
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012