Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation (NO PERS-AF)

Haukeland University Hospital

Status

Completed

Conditions

Persistent Atrial Fibrillation

Treatments

Procedure: Pulmonary vein isolation with cryoballoon catheter.

Procedure: Pulmonary vein isolation with radiofrequency ablation.

Study type

Interventional

Funder types

Other

Identifiers

NCT03008811

2016/27

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.