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Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Magnetic navigation
Ablation performed with manual navigation
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Ablation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing ablation for atrial fibrillation at St. Olavs Hospital
  • Implanted Reveal

Sites / Locations

  • Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Magnetic navigation

Manual navigation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Procedure time
Duration of the 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.
Exposure of radiation to health personnel involved in the procedure
Total time with use of of radiation equipment. Radiation exposure of the operator.
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
Pain
Pain scores on the Visual Analog Scale
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.
Time with active ablation
Total time that electrical current has been used during the ablation
Total time nurses are occupied with the ablation
As a measure of cost and resources needed for the procedure
Myocardial damage
Measured by Troponin-t and CK-MBAs
Cardiac volumes and function
Measured by echocardiography
Quality of life
Measured by SF-36 and atrial fibrillation symptoms and severity checklist

Full Information

First Posted
June 8, 2011
Last Updated
March 15, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, SINTEF Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT01407588
Brief Title
Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation
Official Title
Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, SINTEF Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic navigation
Arm Type
Experimental
Arm Title
Manual navigation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Magnetic navigation
Intervention Description
Ablation with use of the magnetic navigation system
Intervention Type
Procedure
Intervention Name(s)
Ablation performed with manual navigation
Intervention Description
Atrial fibrillation ablation performed with manual navigation
Primary Outcome Measure Information:
Title
Number of participants with recurrence of atrial fibrillation after ablation
Description
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
Secondary Outcome Measure Information:
Title
Procedure time
Description
Duration of the ablation procedure
Time Frame
Day 1(after ablation procedure)
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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)
Title
Exposure of radiation to health personnel involved in the procedure
Description
Total time with use of of radiation equipment. Radiation exposure of the operator.
Time Frame
Day 1(after ablation procedure)
Title
Amount of analgetics and sedatives given during procedure
Description
As a measure of pain and discomfort experienced by the patient during the procedure, the amount of medications are assessed
Time Frame
Day 1
Title
Pain
Description
Pain scores on the Visual Analog Scale
Time Frame
After ablation(day 1)
Title
Numbers of and types of catheters used
Description
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)
Title
Time with active ablation
Description
Total time that electrical current has been used during the ablation
Time Frame
During the procedure(Day 1)
Title
Total time nurses are occupied with the ablation
Description
As a measure of cost and resources needed for the procedure
Time Frame
During the ablation(day 1)
Title
Myocardial damage
Description
Measured by Troponin-t and CK-MBAs
Time Frame
After ablation(day 1)
Title
Cardiac volumes and function
Description
Measured by echocardiography
Time Frame
1 year
Title
Quality of life
Description
Measured by SF-36 and atrial fibrillation symptoms and severity checklist
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing ablation for atrial fibrillation at St. Olavs Hospital Implanted Reveal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Paal Loennechen, PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

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