Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT01407588|
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : March 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Procedure: Magnetic navigation Procedure: Ablation performed with manual navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation|
|Actual Study Start Date :||August 2011|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
|Experimental: Magnetic navigation||
Procedure: Magnetic navigation
Ablation with use of the magnetic navigation system
|Experimental: Manual navigation||
Procedure: Ablation performed with manual navigation
Atrial fibrillation ablation performed with manual navigation
- Number of participants with recurrence of atrial fibrillation after ablation [ Time Frame: 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.
- Procedure time [ Time Frame: Day 1(after ablation procedure) ]Duration of the ablation procedure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 ]As a measure of pain and discomfort experienced by the patient during the procedure, the amount of medications are assessed
- Pain [ Time Frame: After ablation(day 1) ]Pain scores on the Visual Analog Scale
- Numbers of and types of catheters used [ Time Frame: 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.
- Time with active ablation [ Time Frame: During the procedure(Day 1) ]Total time that electrical current has been used during the ablation
- Total time nurses are occupied with the ablation [ Time Frame: During the ablation(day 1) ]As a measure of cost and resources needed for the procedure
- Myocardial damage [ Time Frame: After ablation(day 1) ]Measured by Troponin-t and CK-MBAs
- Cardiac volumes and function [ Time Frame: 1 year ]Measured by echocardiography
- Quality of life [ Time Frame: 2 years ]Measured by SF-36 and atrial fibrillation symptoms and severity checklist
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407588
|Norwegian University of Science and Technology|
|Study Chair:||Jan Paal Loennechen, PhD||St. Olavs Hospital|