An Investigator Initiated, Controlled, Prospective, Non-Inferiority, Parallel-Group, randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the Pulmonary Veins with a Cryoballoon Catheter Versus a Radiofrequency Ablation with a ThermoCool Catheter in Patients with Paroxysmal Atrial Fibrillatio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 114

Inclusion Criteria

DI1. Symptomatic PAF with at least two episodes within the last three months and at least one episode documented (30 seconds episode length).
I2. Documented treatment failure for effectiveness of at least one anti-arrhythmic drug (AAD Type I or III, excluding *-blocker and AAD intolerance).
I3. * 18 and * 75 years of age.
I4. Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol.
I5. Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard RF ablation technique. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document. All the details have been presented to him and he has signed the informed consent form for the trial.

Exclusion Criteria

E1. Any disease that limits life expectancy to less than one year.
E2. Participation in another clinical trial (of a drug, device or biologic), either within the past two months or ongoing.
E3. Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomised.
E4. Breastfeeding women.
E5. Substance misuse.
E6. Active systemic infection.
E7. Cryoglobulinaemia.
E8. Previous participation in this clinical trial.
E9. Patients with prosthetic valves.
E10. Employment by the sponsor or by the department of any of the investigators.
E11. Close relatives of any of the investigators.
E12. Any previous LA ablation or surgery.
E13. Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrolment.
E14. Unstable angina pectoris.
E15. Myocardial infarction within three months prior to enrolment.
E16. Symptomatic carotid stenosis.
E17. Chronic obstructive pulmonary disease with detected pulmonary hypertension.
E18. Any condition contraindicating chronic anticoagulation.
E19 Stroke or transient ischemic attack within six months prior to enrolment.
E20. Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
E21. New York Heart Association (NYHA) class III or IV congestive heart failure.
E22. EF < 35 % (determined by echocardiography within 60 days of enrolment as documented in patient medical history).
E23. Anteroposterior LA diameter > 55 mm (by trans-thoracic echocardiography (TTE) within three months to prior enrolment).
E24. LA thrombus (TEE diagnostic performed on admission).
E25. Intracardiac thrombus.
E26. PV diameter > 26 mm in right sided PVs.
E27. Mitral prosthesis.
E28. Hyperthrophic cardiomyopathy.
E29. 2° (Type II) or 3° atrioventricular block.
E30. Brugada syndrome or long QT syndrome.
E31. Arrhythmogenic right ventricular dysplasia.
E32. Sarcoidosis.
E33. PV stent.
E34. Myxoma.
E35. Thrombocytosis (platelet count > 600,000 / µl), thrombocytopenia (platelet count < 100,000 / µl).
E36. Any untreated or uncontrolled hyperthyroidism or hypothyroidism.
E37. Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Time to first documented recurrence of atrial arrhythmias (a blanking period of<br /><br>three months will be maintained after the initial procedure).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Several secondary outcomes will be assessed in the trial population.<br /><br>Key secondary outcomes: Procedural data (total procedural duration, time of<br /><br>fluoroscopy and duration of hospital stay), quality of life, sedation, flutter<br /><br>ablation and survival time.<br /><br>Assessment of safety: serious adverse events during the observation period with<br /><br>special emphasis on complications due to interventions as well as phrenic nerve<br /><br>palsy and PV stenosis.</p><br>