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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| persistent atrial fibrillation | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LA pressure, voltage map, strain, scar-map, blood sampling | Diagnostic Test | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with persistent atrial fibrillation referred for pulmonary vein isolation at Heart and Vascular Center of Semmelweis University, Budapest, Hungary.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Szilvia Herczeg, MD | Contact | 0036206663198 | herczeg.szilvia@med.semmelweis-univ.hu | |
| Nandor Szegedi, MD | Contact | 0036206663442 | szegedi.nandor@med.semmelweis-univ.hu |
| Name | Affiliation | Role |
|---|---|---|
| Laszlo Geller, MD PhD | Heart and Vascular Center of Semmelweis University | Principal Investigator |
| Bela Merkely, MD PhD DSc | Heart and Vascular Center of Semmelweis University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart and Vascular Center of Semmelweis University | Recruiting | Budapest | 1122 | Hungary |
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venous blood samples
|
| pulmonary vein isolation | Procedure | pulmonary vein isolation without creating additional ablation lesions |
|
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 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013180 | Sprains and Strains |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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