Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.

Official Title
-----------------
Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Magnetic navigation
* Procedure: Ablation performed with manual navigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing ablation for atrial fibrillation at St. Olavs Hospital Implanted Reveal
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic navigation<br> | Procedure: Magnetic navigation<br>* Ablation with use of the magnetic navigation system<br>|
| Experimental: Manual navigation<br> | Procedure: Ablation performed with manual navigation<br>* Atrial fibrillation ablation performed with manual navigation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with recurrence of atrial fibrillation after ablation | If the patient have had recurrence or not of atrial fibrillation after ablation. An implanted arrhythmia loop recorder (Reveal XT) is used for monitoring. Recurrence is defined as an attack of atrial fibrillation of more than 2 minutes. It will also be specified if the patient is referred for a second ablation procedure. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Duration of the ablation procedure | Day 1(after ablation procedure) | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Complications during and after the ablation procedure. Major: pericardial tamponade, permanent atrioventricular (AV) block, major bleeding, cerebral embolus, infection, heart failure, death. Minor: minor bleeding and temporary AV block. | Day 1(after ablation procedure) | 
| Exposure of radiation to health personnel involved in the procedure | Total time with use of of radiation equipment. Radiation exposure of the operator. | Day 1(after ablation procedure) | 
| Amount of analgetics and sedatives given during procedure | As a measure of pain and discomfort experienced by the patient during the procedure, the amount of medications are assessed | Day 1 | 
| Pain | Pain scores on the Visual Analog Scale | After ablation(day 1) | 
| Numbers of and types of catheters used | As a measure of resources needed for the procedure, the catheters used are registered. Numbers of and type of catheters are registered and total cost calculated. | During ablation(Day1) | 
| Time with active ablation | Total time that electrical current has been used during the ablation | During the procedure(Day 1) | 
| Total time nurses are occupied with the ablation | As a measure of cost and resources needed for the procedure | During the ablation(day 1) | 
| Myocardial damage | Measured by Troponin-t and CK-MBAs | After ablation(day 1) | 
| Cardiac volumes and function | Measured by echocardiography | 1 year | 
| Quality of life | Measured by SF-36 and atrial fibrillation symptoms and severity checklist | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Ablation