Atrial FibrillationNCT07126600
Data Collection for Echocardiography-Based Software Assessment
An observational study of Atrial Fibrillation and Left Atrial Appendage Closure, run by Anumana, Inc. at 6 sites in United States.
Trial summary
This is a prospective, observational study collecting data from routine clinical care. The information gathered will be used to support the evaluation of a software-based tool. No investigational procedures or treatments are introduced, and all data are obtained as part of standard-of-care activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Closure, Cardiovascular Diseases
- What is being tested?
- No investigational intervention administered
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Jul 2025to 17 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing a standard cardiac procedure as part of routine clinical care.
Who may be able to join
- Undergoing a standard left atrial appendage closure procedure with associated imaging.
Who cannot join
- Did not provide authorization to use data for research purposes.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Buffalo
Amherst, New York, 14228
Massachusetts General Hospital
Boston, Massachusetts, 02114
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Southcoast Hospital
New Bedford, Massachusetts, 02740
Montefiore Medical Center
The Bronx, New York, 10467
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: A Data Collection Study for Echocardiography-Based Software Assessment
This is a prospective, observational study collecting data from routine clinical care. The information gathered will be used to support the evaluation of a software-based tool. No investigational procedures or treatments are introduced, and all data are obtained as part of standard-of-care activities.
Read the detailed description
This is a prospective, observational study designed to collect data from routine clinical procedures related to a specific cardiac intervention. Data will be collected from multiple sites and compiled into a centralized dataset. The dataset will be used to support the evaluation of software-based tools intended to assist in clinical decision-making.
No investigational interventions are introduced as part of the study, and all activities align with standard-of-care practices at participating institutions. The study may also support future analyses related to the performance and usability of the software.
- Being tested
- No investigational intervention administered
- Medical subject headings
- Atrial Fibrillation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No investigational intervention administeredOther
No investigational intervention administered
| Study group | Role | What they receive |
|---|---|---|
| LAAC Patient Cohort | Participants undergoing standard-of-care imaging as part of a left atrial appendage closure (LAAC) procedure. Data will be collected prospectively for software validation purposes. Receives: Other: No investigational intervention administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Imaging-Derived Measurements
Comparison of left atrial appendage measurements (millimeters) from two imaging modalities against a CT-based reference standard.
Measured: At the time of imaging assessment (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start11 Jul 2025
- Primary completion19 Nov 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anumana, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Ptaszek, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126600
- Sponsor's protocol ID
- DOC-2499
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Data Collection Study for Echocardiography-Based Software Assessment
- ClinicalTrials.gov ID
- NCT07126600
- Acronym / sponsor ID
- DOC-2499
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Anumana, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 17 Aug 2025 (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 is a prospective, observational study collecting data from routine clinical care. The information gathered will be used to support the evaluation of a software-based tool. No investigational procedures or treatments are introduced, and all data are obtained as part of standard-of-care activities.
Detailed description
This is a prospective, observational study designed to collect data from routine clinical procedures related to a specific cardiac intervention. Data will be collected from multiple sites and compiled into a centralized dataset. The dataset will be used to support the evaluation of software-based tools intended to assist in clinical decision-making.
No investigational interventions are introduced as part of the study, and all activities align with standard-of-care practices at participating institutions. The study may also support future analyses related to the performance and usability of the software.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAAC Patient Cohort | – | Other: No investigational intervention administeredParticipants undergoing standard-of-care imaging as part of a left atrial appendage closure (LAAC) procedure. Data will be collected prospectively for software validation purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing a standard cardiac procedure as part of routine clinical care.
Key inclusion criteria (1 listed)
- Undergoing a standard left atrial appendage closure procedure with associated imaging.
Key exclusion criteria (1 listed)
- Did not provide authorization to use data for research purposes.
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 |
|---|---|---|
| No investigational intervention administeredNo investigational intervention administered | Other | LAAC Patient Cohort |
Primary outcome
Comparison of Imaging-Derived Measurements
Time frame: At the time of imaging assessment (single study visit)
Comparison of left atrial appendage measurements (millimeters) from two imaging modalities against a CT-based reference standard.
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 24 Dec 2025.
- 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. This study is not recruiting at the moment.
Leon Ptaszek, MD, PhD principal investigator
Massachusetts General Hospital
6 sites 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 Left Atrial Appendage Closure, run by Anumana, Inc. at 6 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 1 inclusion and 1 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Comparison of Imaging-Derived Measurements (time frame: At the time of imaging assessment (single study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.