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Study for Atrial Fibrillation Reduction (SAFARI)

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ClinicalTrials.gov Identifier: NCT00267137
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : May 22, 2006
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation, Bradycardia Device: Pacing Algorithms Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Study for Atrial Fibrillation Reduction (SAFARI)
Study Start Date : September 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Safety/Efficacy

Secondary Outcome Measures :
  1. Various


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267137


  Show 34 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
OverallOfficial: Not Required For IDE Studies

Publications:
ClinicalTrials.gov Identifier: NCT00267137     History of Changes
Other Study ID Numbers: 190
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: May 22, 2006
Last Verified: May 2006

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Pacemaker, Atrial Fibrillation/Therapy

Additional relevant MeSH terms:
Atrial Fibrillation
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes