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OpenTrials
Completed

NCT Number: NCT00267137

Study for Atrial Fibrillation Reduction (SAFARI)

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).

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Key information

Conditions

Atrial Fibrillation, Bradycardia Arrhythmias, Cardiac Atrial Fibrillation Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yuma, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pacing Algorithms

Device

Primary outcomes

  1. Safety/Efficacy

Secondary outcomes

  1. Various

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Ablation Solutions

Industry

Registry information

Important dates

Study start
2002
Primary completion
2005
Study completion
2006
First posted
Dec 20, 2005
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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