Study for Atrial Fibrillation Reduction (SAFARI)

April 6, 2020 updated by: Medtronic Cardiac Rhythm and Heart Failure
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Yuma, Arizona, United States
    • Arkansas
      • Fayetteville, Arkansas, United States
      • Fort Smith, Arkansas, United States
    • California
      • Bakersfield, California, United States
      • Berkeley, California, United States
      • Los Angeles, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Connecticut
      • Stamford, Connecticut, United States
    • Florida
      • Clearwater, Florida, United States
      • Daytona Beach, Florida, United States
      • Ormond Beach, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Lombard, Illinois, United States
      • Springfield, Illinois, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Massachusetts
      • Brighton, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
    • Minnesota
      • Saint Paul, Minnesota, United States
    • New Jersey
      • Paterson, New Jersey, United States
      • Ridgewood, New Jersey, United States
    • New York
      • East Syracuse, New York, United States
      • Rochester, New York, United States
      • Syracuse, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Elyria, Ohio, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety/Efficacy

Secondary Outcome Measures

Outcome Measure
Various

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Not Required For IDE Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2002

Primary Completion (Actual)

September 11, 2005

Study Completion (Actual)

July 21, 2006

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria

December 19, 2005

First Posted (Estimate)

December 20, 2005

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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