The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
51
Ablation with use of the magnetic navigation system
Atrial fibrillation ablation performed with manual navigation
Norwegian University of Science and Technology
Trondheim, Norway
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.
Time frame: 2 years
Procedure time
Duration of the ablation procedure
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Day 1
Pain
Pain scores on the Visual Analog Scale
Time frame: After ablation(day 1)
Numbers of and types of catheters used
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: During ablation(Day1)
Time with active ablation
Total time that electrical current has been used during the ablation
Time frame: During the procedure(Day 1)
Total time nurses are occupied with the ablation
As a measure of cost and resources needed for the procedure
Time frame: During the ablation(day 1)
Myocardial damage
Measured by Troponin-t and CK-MBAs
Time frame: After ablation(day 1)
Cardiac volumes and function
Measured by echocardiography
Time frame: 1 year
Quality of life
Measured by SF-36 and atrial fibrillation symptoms and severity checklist
Time frame: 2 years