Left Atrial Function Analysis for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation

Study Overview
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Brief Summary
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This prospective observational study is designed to describe the factors determining the success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation (AF). These factors - described as left atrial (LA) function - are simultaneously studied by multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous measurements are conducted before the PVI in AF and after the sinus rhythm converted due to PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples. During the one year follow-up period rhythm monitoring is conducted by regular Holter-monitoring. Our aim is to define the predictive values of the above mentioned factors and to create a new score system for predicting PVI success in persistent AF population.

Official Title
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Left Atrial Function Analysis With Multimodal Techniques for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation

Conditions
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Persistent Atrial Fibrillation, Catheter Ablation

Intervention / Treatment
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* Diagnostic Test: LA pressure, voltage map, strain, scar-map, blood sampling
* Procedure: pulmonary vein isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented, symptomatic persistent atrial fibrillation (AF) catheter ablation is indicated aged 18-75 years signed Patient Informed Consent Form able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: secondary AF paroxysmal, long-standing persistent or permanent AF ejection fraction < 30% GFR <30 ml/min/1.73m2 unstable angina pectoris or myocardial infarction within the past 2 months severe heart failure (NYHA IV) severe COPD (GOLD III-IV) previous left atrial catheter ablation previous transthoracic cardiac surgery implanted cardiac device (pacemaker, ICD, CRT, VAD) awaiting cardiac transplantation or other cardiac surgery within the next 12 months any contraindication for pulmonary vein isolation, MRI or anticoagulation coagulopathy active malignancy, left atrial myxoma autoimmune disorder, chronic inflammatory disease acute illness, active systemic infection, sepsis women who are pregnant, breast feeding, or planning to become pregnant in the next 12 months aged under 18 years or above 75 years enrollment in other studies, which exclude participation in other studies patient not willing or not able to sign the informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| persistent atrial fibrillation<br>invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm | Diagnostic Test: LA pressure, voltage map, strain, scar-map, blood sampling<br>* invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm<br>Procedure: pulmonary vein isolation<br>* pulmonary vein isolation without creating additional ablation lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| one-year success of pulmonary vein isolation | one-year success without recurrent atrial fibrillation or atrial tachycardia without antiarrhythmic drugs after the three-month blanking period of pulmonary vein isolation | 3-12 months after the first pulmonary vein isolation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute unsuccessful pulmonary vein isolation | operator is unable to disconnect pulmonary veins from the left atrium | within 5 minutes after the last application is performed at the ablation procedure | 
| usage of antiarrhythmic drugs after the three-month blanking period | antiarrhythmic drugs: sotalol, amiodarone, propafenon | 3-12 months after the first pulmonary vein isolation | 
| reablation | repeated left atrial ablation is performed due to atrial fibrillation or left atrial tachycardia recurrence | 3-12 months after the first pulmonary vein isolation | 
| major complications of pulmonary vein isolation | major complications: requiring surgical intervention or causing prolonged hospitalisation | through 1 year follow-up after the first pulmonary vein isolation | 
| MACE | major adverse cardiac events | through 1 year follow-up after the first pulmonary vein isolation | 
| death |  | through 1 year follow-up after the first pulmonary vein isolation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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persistent atrial fibrillation, pulmonary vein isolation, catheter ablation, left atrial function, left atrial pressure, voltage map, strain, scar, success, biomarker