Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Ablation
Brief summary
The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.
Interventions
PROCEDUREMagnetic navigation
Ablation with use of the magnetic navigation system
PROCEDUREAblation performed with manual navigation
Atrial fibrillation ablation performed with manual navigation
Sponsors
St. Olavs Hospital
SINTEF Health Research
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Undergoing ablation for atrial fibrillation at St. Olavs Hospital * Implanted Reveal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with recurrence of atrial fibrillation after ablation | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Day 1(after ablation procedure) | 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. |
| Exposure of radiation to health personnel involved in the procedure | Day 1(after ablation procedure) | Total time with use of of radiation equipment. Radiation exposure of the operator. |
| Amount of analgetics and sedatives given during procedure | Day 1 | As a measure of pain and discomfort experienced by the patient during the procedure, the amount of medications are assessed |
| Pain | After ablation(day 1) | Pain scores on the Visual Analog Scale |
| Numbers of and types of catheters used | During ablation(Day1) | 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. |
| Procedure time | Day 1(after ablation procedure) | Duration of the ablation procedure |
| Total time nurses are occupied with the ablation | During the ablation(day 1) | As a measure of cost and resources needed for the procedure |
| Myocardial damage | After ablation(day 1) | Measured by Troponin-t and CK-MBAs |
| Cardiac volumes and function | 1 year | Measured by echocardiography |
| Quality of life | 2 years | Measured by SF-36 and atrial fibrillation symptoms and severity checklist |
| Time with active ablation | During the procedure(Day 1) | Total time that electrical current has been used during the ablation |
Countries
Norway
Outcome results
None listed