Assessing heart tissue changes in atrial fibrillation patients
Exploratory Study of Consistency of Bi-Atrial Fibrosis Detected by Late Gadolinium Enhancement Magnetic Resonance Imaging and Low Voltage Area of Electroanatomic Mapping
This study is testing if a special type of MRI can help doctors see heart tissue changes in patients with atrial fibrillation who are getting treatment to improve their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06552845 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the consistency of late gadolinium enhancement MRI (LGE-MRI) in identifying bi-atrial fibrosis and compares it with electroanatomical mapping of low-voltage areas in patients with atrial fibrillation. It aims to characterize different types of fibrosis and their locations within the left and right atrium, as well as to explore the relationship between preoperative and postoperative fibrosis and long-term recurrence of atrial fibrillation. The study involves adult patients who are candidates for catheter ablation and will utilize LGE-MRI scans as part of the assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with atrial fibrillation who are considering catheter ablation.
Not a fit: Patients with contraindications for LGE-MRI or those with severe chronic obstructive pulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of atrial fibrillation and lead to better treatment strategies for patients.
How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in understanding atrial fibrillation through imaging techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent; 2. Atrial fibrillation was diagnosed and catheter ablation was proposed Exclusion Criteria: 1. Left atrial thrombus or left atrial appendage thrombus; 2. Severe chronic obstructive pulmonary disease (FEV1/ FVC\<70%, FEV1\<50% predicted value); 3. Absolute contraindications of anticoagulation therapy; 4. Currently pregnant; 5. Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR\<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.); 6. refuse to participate in the study; 7. other physical or mental incapacity to participate in the study.
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital, CAMS&PUMC — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.