Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation (SD-CRYO-AF)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Ablation, Cryoballoon, Achieve
Eligibility Criteria
Inclusion Criteria:
- Patients with paroxysmal or persistent AF verified by ECG
- Patients with symptoms corresponding to at least Europe Heart Rhythm Association (EHRA) score 2.
Exclusion Criteria:
- Sinus rhythm cannot be maintained for at least one hour after an electrical cardioversion.
- Congestive heart failure with New York Heart Association (NYHA) class 3 or more.
- Left ventricular ejection fraction < 35% not secondary to AF with inadequate rate control, according to the judgement of the investigator.
- Left atrial diameter ≥ 55 mm judged by transthoracic echocardiography.
- Prior AF ablation procedure.
- Longstanding persistent AF
- AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease as well as AF triggered by other uniform supraventricular tachycardia.
- Contraindication to treatment with anticoagulants.
- Significant valvular disease or planned cardiac intervention.
- Hypertrophic cardiomyopathy.
- Recent cardiac disease states within the last 6 months; unstable angina, acute myocardial infarction, revascularisation procedures, valve disease
- Implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device.
- Dual chamber- and single chamber-pacemaker when the patient is pacemaker dependent on ventricular level
- Patients with contraindications for transseptal catheterization or appropriate vascular access is precluded.
- Renal failure requiring dialysis or abnormalities of liver function tests.
- Participant in investigational clinical or device trial.
- Unwilling or unable to give informed consent or inaccessible for follow-up and psychological problem that might limit compliance.
- Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.
Sites / Locations
- Department of Cardiology, University Hospital in Uppsala
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
PVI by single cryoballoon application
PVI by 2 cryo applications
A single cryoballoon application for pulmonary vein isolation will be guided by a Multipolar Recording Catheter (Achieve Mapping Catheter), passed through the inner lumen of the cryoablation catheter. A single application of 4 minutes will be used per vein guided by recording of loss of electrograms and by a defined drop of temperature within 2 minutes application. If a stable position with adequate occlusion of the vein the Achieve catheter should be located proximally for evaluation of entrance block during application, but can be advanced deeper for stability and then retracted to the ostium to evaluate vein isolation (entrance block). If the vein then is isolated after a single application, the operator can move on to the next vein.
Cryoballoon ablation with a conventional guidewire passed through the inner lumen of the catheter for stability will be used. Ablation will be performed with 2 consecutive applications for 4 minutes each in each vein guided by degree of occlusion and temperature drop at the discretion of the physician.