I48.1
Conditions
Interventions
Group 1: Ablation using cryoballon
Group 2: Ablation using radiofrequency energy
Sponsors
Medizinische Klinik IVStädtisches Klinikum Karlsruhe
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Documented PersAF: at least 1 episode of PersAF > 7 days and less than 2 years (at least one episode documented) 2. Age 18-80 years 3. Documented inefficacy of at least 1 AAD including beta- blockers 4. Willigness to have rhythm monitoring performed by either internal loop recorder readings or 7 to 14 day external Event recorder reading
Exclusion criteria
Exclusion criteria: 1.LA size > 55 mm 2. LA thrombus 3. Previous LA ablation/surgery 4. Unstable angina 5. Myocardial infarction within three months 6. Cardiac surgery or PTCA within three months 7. Mitral prosthesis 8. EF <40% 9. Heart failure NYHA III-IV 10. Hypertrophic cardiomyopathy 11. Severe or moderate mitral regurgitation 12. Any condition contraindicating chronic anticoagulation 13. Stroke or TIA within six months 14. Thrombocytosis, thrombocytopenia 15. Pregnancy 16. Uncontrolled hyperthyroidism 17. Life expectancy <1year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined endpoint defined as no episodes of atrial arrhythmias lasting longer that 24 h | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to recurrence of atrial arrhythmia Occurrence of left atrial flutter Early recurrence during blanking perios Atrial arrhythmia of more than 30 seconds Long-term clinical success Total radiation exposure Total procedure duration Bleedings | — |
Countries
Germany
Contacts
Public ContactClaus Schmitt
Medizinische Klinik IVStädtisches Klinikum Karlsruhe
Outcome results
None listed