Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation

Not Applicable

Completed

• Conditions: Persistent Atrial Fibrillation

• Registration Number: NCT03008811
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-02
• Status Verified: 2020-02
• Primary Completion: 2021-04
• Study Completion: 2021-05
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The freedom of any atrial arrhythmias at 12 months.	12 months	The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration \> 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording).

Secondary Outcome Measures

Name	Time	Method
Serious adverse events.	12 months.	Serious adverse events documented
Fluoroscopy time	12 months	Fluoroscopy time documented
Symptoms related to atrial fibrillation.	12 months.	Symptoms related to atrial fibrillation documented
Quality of life - Short Form (SF-36) Heath Survey	12 months.	Short Form (SF-36) Heath Survey filled in by patients.
Ablation time	12 months	Ablation time documented
Procedure duration	12 months	Procedure duration documented
The burden of atrial fibrillation	12 months.	Total duration of atrial fibrillation recorded by 7-day Holter.
Quality of life affected by atrial fibrillation.	12 months.	The Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire will be filled in by patients.
Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias.	12 months.	Hospitalization after the procedre
The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter.	12 months.	Atrial tachycardia or atrial flutter recorded by all types of ECG

Trial Locations

Locations (3)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway