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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| SINTEF Health Research | OTHER |
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The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic navigation | Experimental |
| |
| Manual navigation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic navigation | Procedure | Ablation with use of the magnetic navigation system |
| |
| 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 |
| 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Paal Loennechen, PhD | St. Olavs Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian University of Science and Technology | Trondheim | Norway |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Ablation performed with manual navigation |
| Procedure |
Atrial fibrillation ablation performed with manual navigation |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |