Atrial Fibrillation (AF)LAVE-AFNCT07651046
Left Atrial and Left Ventricular Structural and Functional Evaluation by CCTA for Predicting Post-Ablation Outcomes in Patients With Atrial Fibrillation
An observational study of Atrial Fibrillation (AF), run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This study aims to evaluate whether structural and functional parameters of the left atrium and left ventricle, measured by cardiac computed tomography angiography (CCTA), can predict clinical outcomes after radiofrequency ablation in patients with atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to Aug 2028
- 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: Consecutive patients with paroxysmal or persistent atrial fibrillation referred for first-time radiofrequency catheter ablation at Nanjing First Hospital.
Who may be able to join
- Meet the indications for radiofrequency ablation recommended by relevant atrial fibrillation diagnosis and treatment guidelines
- Age ≥ 18 years
- First-time radiofrequency ablation
Who cannot join
- history of cardiac ablation
- structural heart diseases, such as cardiomyopathy, valvular disease, heart failure, and acute myocardial infarction
- severe renal failure (estimated glomerular filtration rate <30 ml/m2)
- left ventricular (LV) ejection fraction <30%
- poor image quality inadequate for assessment
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing First Hospital, Nanjing Medical University, 68 Changle road, Qinhuai District
Nanjing, Jiangsu, 210006
About this study
Official title: Using CCTA to Assess Heart Function and Predict AF Recurrence After Ablation
This study aims to evaluate whether structural and functional parameters of the left atrium and left ventricle, measured by cardiac computed tomography angiography (CCTA), can predict clinical outcomes after radiofrequency ablation in patients with atrial fibrillation (AF). Atrial fibrillation is a common heart rhythm disorder, and while catheter ablation is an effective treatment, some patients experience recurrence. Current predictive tools have limitations. This prospective observational study will enroll patients with AF scheduled for first-time radiofrequency ablation. All participants will undergo CCTA before the ablation procedure to assess left atrial and left ventricular volumes, ejection fraction, and strain parameters. After ablation, patients will be followed for 12 months to monitor recurrence of atrial arrhythmias. The primary outcome is the recurrence of atrial fibrillation or atrial tachycardia lasting more than 30 seconds after a 3-month blanking period. The study will determine whether CCTA-derived parameters improve risk stratification for post-ablation recurrence. Findings may help identify patients who are more likely to benefit from ablation or who may need additional therapy.
- Conditions
- Atrial Fibrillation (AF)
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial arrhythmia after ablation
Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or longer, documented by electrocardiogram (ECG) or Holter monitoring, after a 3-month blanking period following radiofrequency ablation.
Measured: 12 months after ablation (following the initial 3-month blanking period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start15 Aug 2024
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Why it stopped: Protocol details were entered incorrectly; study withdrawn before any enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651046
- Sponsor's protocol ID
- KY20250327-05
- Acronym
- LAVE-AF
- Status last verified
- May 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using CCTA to Assess Heart Function and Predict AF Recurrence After Ablation
- ClinicalTrials.gov ID
- NCT07651046
- Acronym / sponsor ID
- LAVE-AF / KY20250327-05
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Protocol details were entered incorrectly; study withdrawn before any enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 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 evaluate whether structural and functional parameters of the left atrium and left ventricle, measured by cardiac computed tomography angiography (CCTA), can predict clinical outcomes after radiofrequency ablation in patients with atrial fibrillation (AF). Atrial fibrillation is a common heart rhythm disorder, and while catheter ablation is an effective treatment, some patients experience recurrence. Current predictive tools have limitations. This prospective observational study will enroll patients with AF scheduled for first-time radiofrequency ablation. All participants will undergo CCTA before the ablation procedure to assess left atrial and left ventricular volumes, ejection fraction, and strain parameters. After ablation, patients will be followed for 12 months to monitor recurrence of atrial arrhythmias. The primary outcome is the recurrence of atrial fibrillation or atrial tachycardia lasting more than 30 seconds after a 3-month blanking period. The study will determine whether CCTA-derived parameters improve risk stratification for post-ablation recurrence. Findings may help identify patients who are more likely to benefit from ablation or who may need additional therapy.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with paroxysmal or persistent atrial fibrillation referred for first-time radiofrequency catheter ablation at Nanjing First Hospital.
Key inclusion criteria (3 listed)
- Meet the indications for radiofrequency ablation recommended by relevant atrial fibrillation diagnosis and treatment guidelines
- Age ≥ 18 years
- First-time radiofrequency ablation
Key exclusion criteria (5 listed)
- history of cardiac ablation
- structural heart diseases, such as cardiomyopathy, valvular disease, heart failure, and acute myocardial infarction
- severe renal failure (estimated glomerular filtration rate <30 ml/m2)
- left ventricular (LV) ejection fraction <30%
- poor image quality inadequate for assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence of atrial arrhythmia after ablation
Time frame: 12 months after ablation (following the initial 3-month blanking period)
Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or longer, documented by electrocardiogram (ECG) or Holter monitoring, after a 3-month blanking period following radiofrequency ablation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (AF), run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 3 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: withdrawn, as of the sponsor's last update on 22 Jun 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 China. 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 was withdrawn before enrolling participants, so there are no results.
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?
Recurrence of atrial arrhythmia after ablation (time frame: 12 months after ablation (following the initial 3-month blanking period)). 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 22 Jun 2026.