Back to resultsStudy for Atrial Fibrillation Reduction (SAFARI)
Primary Purpose
Atrial Fibrillation, Bradycardia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pacing Algorithms
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation, Bradycardia focused on measuring Pacemaker, Atrial Fibrillation/Therapy
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Safety/Efficacy
Secondary Outcome Measures
Various
Full Information
NCT ID
NCT00267137
First Posted
December 19, 2005
Last Updated
April 6, 2020
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT00267137
Brief Title
Study for Atrial Fibrillation Reduction (SAFARI)
Official Title
Study for Atrial Fibrillation Reduction (SAFARI)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2002 (Actual)
Primary Completion Date
September 11, 2005 (Actual)
Study Completion Date
July 21, 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Bradycardia
Keywords
Pacemaker, Atrial Fibrillation/Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
540 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pacing Algorithms
Primary Outcome Measure Information:
Title
Safety/Efficacy
Secondary Outcome Measure Information:
Title
Various
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Not Required For IDE Studies
Facility Information:
City
Yuma
State/Province
Arizona
Country
United States
City
Fayetteville
State/Province
Arkansas
Country
United States
City
Fort Smith
State/Province
Arkansas
Country
United States
City
Bakersfield
State/Province
California
Country
United States
City
Berkeley
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Stamford
State/Province
Connecticut
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Daytona Beach
State/Province
Florida
Country
United States
City
Ormond Beach
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Lombard
State/Province
Illinois
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Brighton
State/Province
Massachusetts
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Saint Paul
State/Province
Minnesota
Country
United States
City
Paterson
State/Province
New Jersey
Country
United States
City
Ridgewood
State/Province
New Jersey
Country
United States
City
East Syracuse
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Elyria
State/Province
Ohio
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16875902
Citation
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. doi: 10.1016/j.ahj.2005.11.012.
Results Reference
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Study for Atrial Fibrillation Reduction (SAFARI)
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