Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407588
• Other study ID #: 2010/3345-2
• Status: Completed
• Phase: N/A
• First received: June 8, 2011
• Last updated: March 15, 2017
• Start date: August 2011
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Undergoing ablation for atrial fibrillation at St. Olavs Hospital

• Implanted Reveal

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Magnetic navigation
Ablation with use of the magnetic navigation system
• Ablation performed with manual navigation
Atrial fibrillation ablation performed with manual navigation

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	SINTEF Health Research, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Procedure time	Duration of the ablation procedure	Day 1(after ablation procedure)
Secondary	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.	Day 1(after ablation procedure)
Secondary	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)
Secondary	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
Secondary	Pain	Pain scores on the Visual Analog Scale	After ablation(day 1)
Secondary	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)
Secondary	Time with active ablation	Total time that electrical current has been used during the ablation	During the procedure(Day 1)
Secondary	Total time nurses are occupied with the ablation	As a measure of cost and resources needed for the procedure	During the ablation(day 1)
Secondary	Myocardial damage	Measured by Troponin-t and CK-MBAs	After ablation(day 1)
Secondary	Cardiac volumes and function	Measured by echocardiography	1 year
Secondary	Quality of life	Measured by SF-36 and atrial fibrillation symptoms and severity checklist	2 years