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Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborators:
St. Olavs Hospital
SINTEF Health Research
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01407588
First received: June 8, 2011
Last updated: March 15, 2017
Last verified: March 2017

June 8, 2011
March 15, 2017
August 2011
February 2017   (Final data collection date for primary outcome measure)
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.
Number of participants with recurrence of atrial fibrillation after ablation [ Time Frame: 1 year ]
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.
Complete list of historical versions of study NCT01407588 on ClinicalTrials.gov Archive Site
  • 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
  • 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 people 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 uncomfort experienced by the patient during the procedure, the amount of medications are assessed
  • Pain Scores on the Visual Analog Scale [ Time Frame: After ablation(day 1) ]
    Pain assessed by VAS score is registered after the ablation
  • 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, the total time each nurse is occupied with the ablation procedure will be registered.
  • Myocardial damage measured by Troponin-t and CK-MB [ Time Frame: After ablation(day 1) ]
    As a measure of myocardial damage, troponin-t and CK-MB will be measured the first morning after the ablation.
Not Provided
Not Provided
 
Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation
Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation
The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Atrial Fibrillation
  • Procedure: Magnetic navigation
    Ablation with use of the magnetic navigation system
  • Procedure: Ablation performed with manual navigation
    Atrial fibrillation ablation performed with manual navigation
  • Experimental: Magnetic navigation
    Intervention: Procedure: Magnetic navigation
  • Experimental: Manual navigation
    Intervention: Procedure: Ablation performed with manual navigation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
February 2017
February 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Undergoing ablation for atrial fibrillation at St. Olavs Hospital
  • Implanted Reveal
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01407588
2010/3345-2
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • St. Olavs Hospital
  • SINTEF Health Research
Study Chair: Jan Paal Loennechen, PhD St. Olavs Hospital
Norwegian University of Science and Technology
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP