Clinical trial NCT03008811: Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation
Official title: Norwegian Randomized Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation (NO PERS-AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Catheter Ablation
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University Hospital of North Norway
First posted: 2017-01-02
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.

Detailed description: The purpose of this randomized clinical trial is to compare the efficacy and safety of pulmonary vein isolation with either the second generation cryoballoon (Arctic Front Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia recurrence at 12 months.Treatment success will be evaluated by using 12-lead electrocardiography and 7-day Holter recording.

Eligibility criteria: Inclusion criteria:

* Patients plan to undergo pulmonary vein isolation as the first procedure for symptomatic persistent atrial fibrillation (\>7 days) and longstanding persistent atrial fibrillation (\> 12 months, but ≤ 3 years) who are refractory to at least one class I or class III antiarrhythmic drug and required at least one electrical or pharmacologic cardioversion.
* Subject is at least 18 and ≤ 75 years old.
* Subject is able and willing to give informed consent.

Exclusion criteria:

* Subject has paroxysmal atrial fibrillation (\< 7days) or persistent atrial fibrillation with duration \> 3 years.
* Subject has any previous left atrial ablation procedure or surgery, including pulmonary vein isolation.
* Subject has presence of an intracavitary thrombus.
* Subject has uncontrolled heart failure.
* Subject has severe valvular disease.
* Subject has the left atrial diameter \> 60 mm confirmed by echocardiography.
* Subject has contraindications to systemic anticoagulation with heparin or oral anticoagulants.
* Subject has known cryoglobulinaemia.
* Subject has severe renal dysfunction.
* Subject who is or may potentially be pregnant.
* Subject has unstable angina pectoris.
* Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
* Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension.

Primary outcomes:
measure: The freedom of any atrial arrhythmias at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Procedure duration
timeFrame: 12 months
measure: Fluoroscopy time
timeFrame: 12 months
measure: Ablation time
timeFrame: 12 months
measure: Quality of life - Short Form (SF-36) Heath Survey
timeFrame: 12 months.
measure: Quality of life affected by atrial fibrillation.
timeFrame: 12 months.
measure: Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias.
timeFrame: 12 months.
measure: The burden of atrial fibrillation
timeFrame: 12 months.
measure: The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter.
timeFrame: 12 months.
measure: Symptoms related to atrial fibrillation.
timeFrame: 12 months.
measure: Serious adverse events.
timeFrame: 12 months.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
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