Clinical trial NCT00267137: Study for Atrial Fibrillation Reduction (SAFARI)
Official title: Study for Atrial Fibrillation Reduction (SAFARI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation, Bradycardia
Keywords: Pacemaker, Atrial Fibrillation/Therapy
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2005-12-20
Enrollment: 540
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Safety/Efficacy
Secondary outcomes:
measure: Various
Other outcomes:
Locations:
city: Yuma
country: United States
state: Arizona
city: Fayetteville
country: United States
state: Arkansas
city: Fort Smith
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Berkeley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Lombard
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Brighton
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Saint Paul
country: United States
state: Minnesota
city: Paterson
country: United States
state: New Jersey
city: Ridgewood
country: United States
state: New Jersey
city: East Syracuse
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Elyria
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
name: Not Required For IDE Studies
References:
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.