A prospective, randomized, controlled, non-inferiority trial comparing RF- energy and cryoenergy in pulmonary vein isolation in patients with persistent atrial fibrillatio

Phase 4

• Conditions: I48.1; Persistent atrial fibrillation

• Registration Number: DRKS00010840
• Lead Sponsor: Medizinische Klinik IVStädtisches Klinikum Karlsruhe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 340

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined endpoint defined as no episodes of atrial arrhythmias lasting longer that 24 h

Secondary Outcome Measures

Name	Time	Method
Time to recurrence of atrial arrhythmia<br>Occurrence of left atrial flutter<br>Early recurrence during blanking perios<br>Atrial arrhythmia of more than 30 seconds<br>Long-term clinical success<br>Total radiation exposure<br>Total procedure duration<br>Bleedings