About this trial
evaluate the impact of various features in CMR on the mid-term/long-term success rate of rhythm control for paroxysmal atrial fibrillation/flutter .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age>18 years.
Patients undergoing successful cardioversion (pharmacologic or electric) for atrial fibrillation/flutter, OR symptomatic patients with paroxysmal atrial fibrillation/flutter scheduled for trans-catheter ablation.
Index cardioversion OR Index ablation procedure.
Disqualifiers
LA thrombus on TEE or CMR.
Contraindications to CMR.
Contraindications to Gd-based contrast.
Trial population
Based on the previously reported antiarrhythmic drug efficacy of 52% in maintaining sinus rhythm: * For Wilcoxon-Mann-Whitney test for difference in 2 group means: assuming an alpha error probability of 0.05, a study power of 60-70%, and a 1:1 ratio of successful rhythm control vs atrial fibrillation/flutter recurrence, a total sample size of 86-106 would be needed (43-53 for each arm). \[calculated by G\*Power software v.3.1.9.7\] * To be able to build multivariable logistic regression models including, e.g., 4-5 predictor variables, a reasonable sample size would be 80-100 patients. * Patient enrollment will continue until the projected sample size is satisfied or until 24 months have lapsed, whichever comes first.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Recurence in patient with AF or flutter after pharmacological or interventional rythm control
* Non-invasive rhythm control arm: Predictors of atrial fibrillation recurrence within 6 months of cardioversion or the need for ≥2 cardioversions in the 1st year after initial cardioversion. * Ablation arm: Predictors of success rate (acute and mid term) of ablation on multivariable logistic regression analysis.
Secondary outcomes
parameters for safe ablation
* Ablation arm: Predictors of esophageal thermal injury (ETI). * Arterial embolic events in both arms.
Sponsors and contacts
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