Catheter Ablation, Persistent Atrial Fibrillation
Conditions
Keywords
persistent atrial fibrillation, pulmonary vein isolation, catheter ablation, left atrial function, left atrial pressure, voltage map, strain, scar, success, biomarker
Brief summary
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.
Interventions
DIAGNOSTIC_TESTLA pressure, voltage map, strain, scar-map, blood sampling
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
PROCEDUREpulmonary vein isolation
pulmonary vein isolation without creating additional ablation lesions
Sponsors
Semmelweis University Heart and Vascular Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| one-year success of pulmonary vein isolation | 3-12 months after the first 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| usage of antiarrhythmic drugs after the three-month blanking period | 3-12 months after the first pulmonary vein isolation | antiarrhythmic drugs: sotalol, amiodarone, propafenon |
| reablation | 3-12 months after the first pulmonary vein isolation | repeated left atrial ablation is performed due to atrial fibrillation or left atrial tachycardia recurrence |
| acute unsuccessful pulmonary vein isolation | within 5 minutes after the last application is performed at the ablation procedure | operator is unable to disconnect pulmonary veins from the left atrium |
| MACE | through 1 year follow-up after the first pulmonary vein isolation | major adverse cardiac events |
| death | through 1 year follow-up after the first pulmonary vein isolation | — |
| major complications of pulmonary vein isolation | through 1 year follow-up after the first pulmonary vein isolation | major complications: requiring surgical intervention or causing prolonged hospitalisation |
Countries
Hungary
Contacts
Primary ContactSzilvia Herczeg, MD
Backup ContactNandor Szegedi, MD
Outcome results
None listed