Atrial Fibrillation (AF)ELATE-AFNCT07647939
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
A study testing Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus and Delayed Gated CT Scan for Left Atrial Appendage Thrombus in people with Atrial Fibrillation (AF) and Pulmonary Embolism (PE), run by Northwell Health at 1 site in United States.
Trial summary
This study aims to investigate whether a quick, additional CT scan of the heart, performed immediately after a standard CT scan for pulmonary embolism, can effectively detect blood clots in the left atrial appendage (LAA) in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Pulmonary Embolism (PE), Left Atrial Appendage Thrombosis
- What is being tested?
- Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus and Delayed Gated CT Scan for Left Atrial Appendage Thrombus
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 years of age years deemed candidates for CT angiography for pulmonary embolism by the primary team on clinical grounds and noted to be in atrial fibrillation at the time.
- Room air oxygen saturation above 92%
- Systolic blood pressure above 100 mm Hg
- Respiratory rate less than 24 breaths/min
Who cannot join
- Inability to personally give informed consent
- Pregnant or breastfeeding individuals
- Stroke like symptoms
- ECG criteria for ischemia or infarction
- Heart rate <40 or > 120 bpm (inclusive) or 3rd degree heart block
- Unable to lie flat for at least 10 minutes
Show all 9Show fewer
- Unable to follow simple commands
- Northwell Health Employees.
- Non-English-speaking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
Tabetha Garver-Mosher, 516-562-0100 ext. 1514, tgarvermosher@northwell.edu
Ana Centeno Rahbani, acentenorahb@northwell.edu
About this study
This study aims to investigate whether a quick, additional CT scan of the heart, performed immediately after a standard CT scan for pulmonary embolism, can effectively detect blood clots in the left atrial appendage (LAA) in patients with atrial fibrillation. Detecting these clots is crucial before certain heart procedures to prevent stroke. Currently, a different, more involved procedure (Transesophageal Echocardiography - TEE) is often used. This study will assess if this additional CT scan is feasible, meaning if it can provide clear enough images to identify LAA clots without needing more contrast dye. The study will involve 60 patients, half receiving an "ungated" CT scan and the other half a "gated" CT scan (timed with their heart rhythm). The results of these scans will not be used for immediate patient care during the study, but rather to evaluate the CT scan technique itself. There is no direct benefit to participants, but the information gained could lead to faster diagnosis and reduced unnecessary testing for future patients.
- Being tested
- Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus, Delayed Gated CT Scan for Left Atrial Appendage Thrombus
- Medical subject headings
- Atrial Fibrillation, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Un-gated CT Scan for Left Atrial Appendage ThrombusDevice
Patients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed un-gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot. No additional intravenous contrast will be given.
Delayed Gated CT Scan for Left Atrial Appendage ThrombusDevice
Patients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot. No additional intravenous contrast will be given.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Un-gated CT Scan Arm | Experimental | This arm will include the first 30 patients, who will undergo a 60-second delayed, un-gated CT scan to assess the left atrial appendage. Receives: Device: Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus |
| Delayed Gated CT Scan Arm | Experimental | This arm will include the subsequent 30 patients, who will undergo a 60-second delayed, gated CT scan to assess the left atrial appendage. Receives: Device: Delayed Gated CT Scan for Left Atrial Appendage Thrombus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Indeterminate Left Atrial Appendage (LAA) Thrombus Scans
The primary endpoint of this study is to test the hypothesis that less than or equal to 20% of the repeat CT scan (described above) will be indeterminate for the presence or absence of left atrial appendage thrombus. Additionally, the proportion of indeterminate gated CT scans will be compared to the proportion of indeterminate ungated CT scans.
Measured: The overall assessment and statistical analysis of this primary outcome for feasibility determination will be conducted at the study completion, an average of one year.
Secondary outcomes (1)
Diagnostic Accuracy of Repeat CT Scan for Left Atrial Appendage (LAA) Thrombus Detection.
The secondary outcome of this study will be calculation of the negative and positive predictive value of this additional CT scan for detection of left atrial appendage thrombus, in the study population.
Measured: The secondary outcome will only be calculated at the end of the study (expected date of one year from the first enrollment) if statistically appropriate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a non-randomized, sequential group assignment.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647939
- Sponsor's protocol ID
- 24-0413-North Shore University
- Acronym
- ELATE-AF
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Senadeera SC, Palmer DG, Keenan R, Beharry J, Yuh Lim J, Hurrell MA, Mouthaan P, Fink JN, Wilson D, Lim A, Wu TY. Left Atrial Appendage Thrombus Detected During Hyperacute Stroke Imaging Is Associated With Atrial Fibrillation. Stroke. 2020 Dec;51(12):3760-3764. doi: 10.1161/STROKEAHA.120.030258. Epub 2020 Nov 9.
PubMed 33161849Pathan F, Hecht H, Narula J, Marwick TH. Roles of Transesophageal Echocardiography and Cardiac Computed Tomography for Evaluation of Left Atrial Thrombus and Associated Pathology: A Review and Critical Analysis. JACC Cardiovasc Imaging. 2018 Apr;11(4):616-627. doi: 10.1016/j.jcmg.2017.12.019.
PubMed 29622180Ng AC, Adikari D, Yuan D, Lau JK, Yong AS, Chow V, Kritharides L. The Prevalence and Incidence of Atrial Fibrillation in Patients with Acute Pulmonary Embolism. PLoS One. 2016 Mar 1;11(3):e0150448. doi: 10.1371/journal.pone.0150448. eCollection 2016.
PubMed 26930405Shinkins B, Thompson M, Mallett S, Perera R. Diagnostic accuracy studies: how to report and analyse inconclusive test results. BMJ. 2013 May 16;346:f2778. doi: 10.1136/bmj.f2778. No abstract available.
PubMed 23682043Wang RC, Miglioretti DL, Marlow EC, Kwan ML, Theis MK, Bowles EJA, Greenlee RT, Rahm AK, Stout NK, Weinmann S, Smith-Bindman R. Trends in Imaging for Suspected Pulmonary Embolism Across US Health Care Systems, 2004 to 2016. JAMA Netw Open. 2020 Nov 2;3(11):e2026930. doi: 10.1001/jamanetworkopen.2020.26930.
PubMed 33216141
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07647939
- Acronym / sponsor ID
- ELATE-AF / 24-0413-North Shore University
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jun 2026 (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.
This study aims to investigate whether a quick, additional CT scan of the heart, performed immediately after a standard CT scan for pulmonary embolism, can effectively detect blood clots in the left atrial appendage (LAA) in patients with atrial fibrillation. Detecting these clots is crucial before certain heart procedures to prevent stroke. Currently, a different, more involved procedure (Transesophageal Echocardiography - TEE) is often used. This study will assess if this additional CT scan is feasible, meaning if it can provide clear enough images to identify LAA clots without needing more contrast dye. The study will involve 60 patients, half receiving an "ungated" CT scan and the other half a "gated" CT scan (timed with their heart rhythm). The results of these scans will not be used for immediate patient care during the study, but rather to evaluate the CT scan technique itself. There is no direct benefit to participants, but the information gained could lead to faster diagnosis and reduced unnecessary testing for future patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This is a non-randomized, sequential group assignment.
| Arm | Type | Receives |
|---|---|---|
| Delayed Un-gated CT Scan Arm | Experimental | Device: Delayed Un-gated CT Scan for Left Atrial Appendage ThrombusThis arm will include the first 30 patients, who will undergo a 60-second delayed, un-gated CT scan to assess the left atrial appendage. |
| Delayed Gated CT Scan Arm | Experimental | Device: Delayed Gated CT Scan for Left Atrial Appendage ThrombusThis arm will include the subsequent 30 patients, who will undergo a 60-second delayed, gated CT scan to assess the left atrial appendage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients above 18 years of age years deemed candidates for CT angiography for pulmonary embolism by the primary team on clinical grounds and noted to be in atrial fibrillation at the time.
- Room air oxygen saturation above 92%
- Systolic blood pressure above 100 mm Hg
- Respiratory rate less than 24 breaths/min
Key exclusion criteria (9 listed)
- Inability to personally give informed consent
- Pregnant or breastfeeding individuals
- Stroke like symptoms
- ECG criteria for ischemia or infarction
- Heart rate <40 or > 120 bpm (inclusive) or 3rd degree heart block
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 |
|---|---|---|
| Delayed Un-gated CT Scan for Left Atrial Appendage ThrombusPatients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed un-gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot. No additional intravenous contrast will be given. | Device | Delayed Un-gated CT Scan Arm |
| Delayed Gated CT Scan for Left Atrial Appendage ThrombusPatients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot. No additional intravenous contrast will be given. | Device | Delayed Gated CT Scan Arm |
Primary outcome
Percentage of Indeterminate Left Atrial Appendage (LAA) Thrombus Scans
Time frame: The overall assessment and statistical analysis of this primary outcome for feasibility determination will be conducted at the study completion, an average of one year.
The primary endpoint of this study is to test the hypothesis that less than or equal to 20% of the repeat CT scan (described above) will be indeterminate for the presence or absence of left atrial appendage thrombus. Additionally, the proportion of indeterminate gated CT scans will be compared to the proportion of indeterminate ungated CT scans.
1 secondary outcome
Diagnostic Accuracy of Repeat CT Scan for Left Atrial Appendage (LAA) Thrombus Detection.
Time frame: The secondary outcome will only be calculated at the end of the study (expected date of one year from the first enrollment) if statistically appropriate.
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 26 Oct 2026.
- Background: PubMed 33161849Senadeera SC, Palmer DG, Keenan R, Beharry J, Yuh Lim J, Hurrell MA, Mouthaan P, Fink JN, Wilson D, Lim A, Wu TY. Left Atrial Appendage Thrombus Detected During Hyperacute Stroke Imaging Is Associated With Atrial Fibrillation. Stroke. 2020 Dec;51(12):3760-3764. doi: 10.1161/STROKEAHA.120.030258. Epub 2020 Nov 9.
- Background: PubMed 29622180Pathan F, Hecht H, Narula J, Marwick TH. Roles of Transesophageal Echocardiography and Cardiac Computed Tomography for Evaluation of Left Atrial Thrombus and Associated Pathology: A Review and Critical Analysis. JACC Cardiovasc Imaging. 2018 Apr;11(4):616-627. doi: 10.1016/j.jcmg.2017.12.019.
- Background: PubMed 26930405Ng AC, Adikari D, Yuan D, Lau JK, Yong AS, Chow V, Kritharides L. The Prevalence and Incidence of Atrial Fibrillation in Patients with Acute Pulmonary Embolism. PLoS One. 2016 Mar 1;11(3):e0150448. doi: 10.1371/journal.pone.0150448. eCollection 2016.
- Background: PubMed 23682043Shinkins B, Thompson M, Mallett S, Perera R. Diagnostic accuracy studies: how to report and analyse inconclusive test results. BMJ. 2013 May 16;346:f2778. doi: 10.1136/bmj.f2778. No abstract available.
- Background: PubMed 33216141Wang RC, Miglioretti DL, Marlow EC, Kwan ML, Theis MK, Bowles EJA, Greenlee RT, Rahm AK, Stout NK, Weinmann S, Smith-Bindman R. Trends in Imaging for Suspected Pulmonary Embolism Across US Health Care Systems, 2004 to 2016. JAMA Netw Open. 2020 Nov 2;3(11):e2026930. doi: 10.1001/jamanetworkopen.2020.26930.
- Individual participant dataSharing planned: No
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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.
North Shore University Hospital
Manhasset, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus and Delayed Gated CT Scan for Left Atrial Appendage Thrombus in people with Atrial Fibrillation (AF) and Pulmonary Embolism (PE), run by Northwell Health 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Indeterminate Left Atrial Appendage (LAA) Thrombus Scans (time frame: The overall assessment and statistical analysis of this primary outcome for feasibility determination will be conducted at the study completion, an average of one year.). 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 NCT07647939, which also lists 5 linked publications.
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 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.