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Study for Atrial Fibrillation Reduction (SAFARI)

This study has been completed.
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure Identifier:
First received: December 19, 2005
Last updated: May 19, 2006
Last verified: May 2006
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
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Study for Atrial Fibrillation Reduction (SAFARI)

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • Safety/Efficacy

Secondary Outcome Measures:
  • Various

Estimated Enrollment: 540
Study Start Date: September 2002

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00267137

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

Publications: Identifier: NCT00267137     History of Changes
Other Study ID Numbers: 190
Study First Received: December 19, 2005
Last Updated: May 19, 2006

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 21, 2017