I48
Conditions
Interventions
Group 1: In this prospective study, patients with atrial fibrillation who are scheduled for pulmonary vein isolation (PVI) are included. PVI is performed using one of three established ablation techni
Sponsors
Herzzentrum Bad Krozingen
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Male and female patients aged =18 years and <90 years with atrial fibrillation diagnosis Patient who undergo first catheter ablation for atrial fibrillation Written informed consent for study participation prior to enrollment Ability to understand the nature of the trial and the trial related procedures and to comply with them
Exclusion criteria
Exclusion criteria: 1. Prior cardiac surgery or left atrial catheter ablation 2. Any of the following atrial conditions: left atrial anteroposterior diameter =5.5 cm (assessed by TTE), current left atrial thrombus 3. Any prior atrial endocardial or epicardial ablation procedure 4. Medical conditions that could prevent participation in the study, interfere with assessments or treatment, significantly increase the risk of participation, or affect the outcome data or its interpretation: Body mass index >40.0 kg/m2, impaired renal function GFR < 70ml/min, hyperthyroidism TSH < 0,4 mU/l, heart failure NYHA IV and acute inflammatory or infectious disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Comparison of systemic effects between various ablation energy modalities by analysis of biomarkers for myocardial injury, inflammation, neurohormonal activation and coagulation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: •Comparison of treatments regarding immediate success rates (pulmonary vein isolation) and recurrence of any arrhythmia. • Evaluation of the prognostic value of biomarkers for the occurrence of adverse events within 12 months of follow-up to serve as a safety endpoint • Investigating whether certain biomarkers are linked to arrhythmia recurrence within 12 months, functioning as a prognostic endpoint for treatment efficacy • Description of predictive potential of biomarkers for arrhythmia free survival. • Correlation of biomarkers for myocardial injury, inflammation, neurohormonal activation and coagulation and mechanical and electrical function of the left atrium as assessed in electroanatomical mapping (only in a subgroup of patients undergoing PVI using 3D mapping), TTE and ECG | — |
Countries
Germany
Contacts
Public ContactBao Dinh
Herzzentrum Bad Krozingen
Outcome results
None listed