Atrial Fibrillation, BradycardiaNCT00267137
Study for Atrial Fibrillation Reduction (SAFARI)
A study testing Pacing Algorithms in people with Atrial Fibrillation, Bradycardia, run by Medtronic Cardiac Ablation Solutions at 34 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Bradycardia
- What is being tested?
- Pacing Algorithms
- Type of treatment
- Medical device
- How many people
- 540 participants
- Where
- 34 sitesUnited States
- Study dates
- Sep 2002to 21 Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Bakersfield, California
Study site
Berkeley, California
Study site
Brighton, Massachusetts
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Daytona Beach, Florida
Study site
East Syracuse, New York
Study site
Elyria, Ohio
Study site
Fayetteville, Arkansas
Study site
Fort Smith, Arkansas
Study site
Houston, Texas
Study site
Lansing, Michigan
Study site
Lombard, Illinois
Study site
Los Angeles, California
Study site
Nashville, Tennessee
Study site
Ormond Beach, Florida
Study site
Paterson, New Jersey
Study site
Pittsburgh, Pennsylvania
Study site
Ridgewood, New Jersey
Study site
Rochester, New York
Study site
Saint Paul, Minnesota
Study site
Shreveport, Louisiana
Study site
Springfield, Illinois
Study site
Stamford, Connecticut
Study site
Syracuse, New York
Study site
Tampa, Florida
Study site
Yuma, Arizona
About this study
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).
- Conditions
- Atrial Fibrillation, Bradycardia
- Being tested
- Pacing Algorithms
- Keywords
- Pacemaker, Atrial Fibrillation/Therapy
- Medical subject headings
- Atrial Fibrillation, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing AlgorithmsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Efficacy
Secondary outcomes (1)
Various
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2005 (estimated)
- Study startSep 2002
- Primary completion11 Sep 2005
- Study completion21 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation, BradycardiaStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 540 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Not Required For IDE Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267137
- Sponsor's protocol ID
- 190
- Status last verified
- Feb 2025
- First submitted
- 19 Dec 2005
- Last updated
- 13 Feb 2025
- Results posted
- No
Publications
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.
PubMed 16875902
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Atrial Fibrillation Reduction (SAFARI)
- ClinicalTrials.gov ID
- NCT00267137
- Acronym / sponsor ID
- 190
- Conditions
- Atrial Fibrillation, Bradycardia
- Keywords
- Pacemaker, Atrial Fibrillation/Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- Sep 2002 (actual)
- Primary completion
- 11 Sep 2005 (actual)
- Study completion
- 21 Jul 2006 (actual)
- First posted
- 20 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacing Algorithms | Device | – |
Primary outcome
Safety/Efficacy
1 secondary outcome
Various
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 16875902Gold 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Not Required For IDE Studies
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacing Algorithms in people with Atrial Fibrillation, Bradycardia, run by Medtronic Cardiac Ablation Solutions at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Efficacy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00267137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.