Study for Atrial Fibrillation Reduction (SAFARI)

Atrial Fibrillation, Bradycardia Clinical Trial

Official title:

Study for Atrial Fibrillation Reduction (SAFARI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267137
• Other study ID #: 190
• Status: Completed
• Phase: N/A
• Start date: September 2002
• Est. completion date: July 21, 2006

Study information

• Verified date: April 2020
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: July 21, 2006
• Est. primary completion date: September 11, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Bradycardia
• Bradycardia

Intervention

Device:
• Pacing Algorithms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/Efficacy
Secondary	Various