NCT07651046

Brief 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). 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
22mo left

Started Aug 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Aug 2024Aug 2028

Study Start

First participant enrolled

August 15, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

June 22, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

June 11, 2026

Last Update Submit

June 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months after ablation (following the initial 3-month blanking period)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with paroxysmal or persistent atrial fibrillation referred for first-time radiofrequency catheter ablation at Nanjing First Hospital.

You may qualify if:

  • Meet the indications for radiofrequency ablation recommended by relevant atrial fibrillation diagnosis and treatment guidelines
  • Age ≥ 18 years
  • First-time radiofrequency ablation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University, 68 Changle road, Qinhuai District

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 16, 2026

Study Start

August 15, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

June 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations