Atrial FibrillationGWTG-AFNCT06245187
Get With the Guidelines Atrial Fibrillation Registry
An observational study of Atrial Fibrillation and Atrial Flutter, run by American Heart Association at 1 site in United States.
Trial summary
Get With The Guidelines-Atrial Fibrillation is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their AFib patients. At the same time, it offers a means of monitoring the quality of AFib care in U.S. Read more about this study
- Who is it for?
- Ages 18 to 125 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- GWTG Atrial Fibrillation program
- How many people
- 17,198 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2040
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 125 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is patients with the diagnosis of nonvalvular Atrial Fibrillation or Atrial Flutter.
Who may be able to join
- Patients hospitalized with nonvalvular Atrial Fibrillation or Atrial Flutter
Who cannot join
- Patients who do not have nonvalvular Atrial Fibrillation or Atrial Flutter
- Patients under 18 years of age
- Patients not admitted as inpatients.
- Patients on comfort care only
- Patients discharged to hospice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christine Rutan contact
United States1 site, 1 recruiting
- Recruiting
Amy Bennett
Dallas, Texas, 75231
Amy Bennett, JD, 214-706-4881, amy.bennett@heart.org
Christine Rutan, Christine.Rutan@heart.org
About this study
Official title: Get With the Guidelines-Atrial Fibrillation
Get With The Guidelines-Atrial Fibrillation is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their AFib patients. At the same time, it offers a means of monitoring the quality of AFib care in U.S. hospitals and building a database for continued research and further quality improvement.
Read the detailed description
Get With The Guidelines-Atrial Fibrillation was initiated in 2013 with over 88 U.S. hospitals participating is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their AFib patients. At the same time, it offers a means of monitoring the quality of AFib care in U.S. hospitals and building a database for continued research and further quality improvement.
Achievement measures tracked through Get With The Guidelines-Atrial Fibrillation:
- ACEI/ARB at discharge for LVSD
- Assessment of thromboembolic risk factors
- Beta Blocker at discharge
- Discharged on FDA-approved anticoagulation therapy
- PT/INR planned follow-up
- Statin at discharge in AF patients with CAD, CVA/TIA or PVD.
Quality measures tracked through Get With The Guidelines-Atrial Fibrillation:
- Aldosterone antagonist at discharge
- Atrial fibrillation patient education
- Anticoagulation therapy education
- CHA2DS2-VASC reported
- Discharge heart rate <110bpm
- Smoking cessation
- Warfarin at discharge for valvular atrial fibrillation
Additional measures collected by Get With The Guidelines-Atrial Fibrillation can be viewed at: http://www.heart.org/idc/groups/heart-public/@private/@wcm/@hcm/@gwtg/documents/downloadable/ucm_451183.pdf
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- GWTG Atrial Fibrillation program
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GWTG Atrial Fibrillation programOther
Evidence based recommended therapies and counseling prior to hospital discharge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Tamponade and/or Pericardiocentesis Following Ablation
Percent of patients with cardiac tamponade and/or pericardiocentesis occurring within 30 days following ablation procedure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study startJan 2013
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
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 FibrillationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 17,198 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javed Butler, MD, Principal investigator, American Heart Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245187
- Sponsor's protocol ID
- 002
- Acronym
- GWTG-AF
- Status last verified
- Jan 2024
- First submitted
- 23 Feb 2016
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
PubMed 24685669
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get With the Guidelines-Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06245187
- Acronym / sponsor ID
- GWTG-AF / 002
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 17,198 participants (estimated)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 7 Feb 2024 (actual)
- 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.
Get With The Guidelines-Atrial Fibrillation is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their AFib patients. At the same time, it offers a means of monitoring the quality of AFib care in U.S. hospitals and building a database for continued research and further quality improvement.
Detailed description
Get With The Guidelines-Atrial Fibrillation was initiated in 2013 with over 88 U.S. hospitals participating is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their AFib patients. At the same time, it offers a means of monitoring the quality of AFib care in U.S. hospitals and building a database for continued research and further quality improvement.
Achievement measures tracked through Get With The Guidelines-Atrial Fibrillation:
- ACEI/ARB at discharge for LVSD
- Assessment of thromboembolic risk factors
- Beta Blocker at discharge
- Discharged on FDA-approved anticoagulation therapy
- PT/INR planned follow-up
- Statin at discharge in AF patients with CAD, CVA/TIA or PVD.
Quality measures tracked through Get With The Guidelines-Atrial Fibrillation:
- Aldosterone antagonist at discharge
- Atrial fibrillation patient education
- Anticoagulation therapy education
- CHA2DS2-VASC reported
- Discharge heart rate <110bpm
- Smoking cessation
- Warfarin at discharge for valvular atrial fibrillation
Additional measures collected by Get With The Guidelines-Atrial Fibrillation can be viewed at: http://www.heart.org/idc/groups/heart-public/@private/@wcm/@hcm/@gwtg/documents/downloadable/ucm_451183.pdf
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients with the diagnosis of nonvalvular Atrial Fibrillation or Atrial Flutter.
Key inclusion criteria (1 listed)
- Patients hospitalized with nonvalvular Atrial Fibrillation or Atrial Flutter
Key exclusion criteria (5 listed)
- Patients who do not have nonvalvular Atrial Fibrillation or Atrial Flutter
- Patients under 18 years of age
- Patients not admitted as inpatients.
- Patients on comfort care only
- Patients discharged to hospice.
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 |
|---|---|---|
| GWTG Atrial Fibrillation programEvidence based recommended therapies and counseling prior to hospital discharge. | Other | – |
Primary outcome
Cardiac Tamponade and/or Pericardiocentesis Following Ablation
Time frame: 30 days
Percent of patients with cardiac tamponade and/or pericardiocentesis occurring within 30 days following ablation procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 24685669January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Christine Rutan contact
Javed Butler, MD principal investigator
American Heart Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by American Heart Association at 1 site 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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Bennett, JD (214-706-2237, amy.bennett@heart.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Tamponade and/or Pericardiocentesis Following Ablation (time frame: 30 days). 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 NCT06245187, 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 29 Jan 2025.