Study for Atrial Fibrillation Reduction (SAFARI)

NCT ID: NCT00267137

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2006-07-21

Brief Summary

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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).

Detailed Description

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Conditions

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Atrial Fibrillation, Bradycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Pacing Algorithms

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role lead

Principal Investigators

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Not Required For IDE Studies

Role:

Locations

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Yuma, Arizona, United States

Site Status

Fayetteville, Arkansas, United States

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Fort Smith, Arkansas, United States

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Bakersfield, California, United States

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Berkeley, California, United States

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Los Angeles, California, United States

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Aurora, Colorado, United States

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Stamford, Connecticut, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Ormond Beach, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Lombard, Illinois, United States

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Springfield, Illinois, United States

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Shreveport, Louisiana, United States

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Brighton, Massachusetts, United States

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Lansing, Michigan, United States

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Saint Paul, Minnesota, United States

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Paterson, New Jersey, United States

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Ridgewood, New Jersey, United States

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East Syracuse, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Elyria, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16875902 (View on PubMed)

Other Identifiers

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190

Identifier Type: -

Identifier Source: org_study_id

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