Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Magnetic navigation; Procedure: Ablation performed with manual navigation

• Registration Number: NCT01407588
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-08
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-01
• Study First Posted: 2011-08-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic navigation	Magnetic navigation	-
Manual navigation	Ablation performed with manual navigation	-

Primary Outcome Measures

Name	Time	Method
Number of participants with recurrence of atrial fibrillation after ablation	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.

Secondary Outcome Measures

Name	Time	Method
Pain	After ablation(day 1)	Pain scores on the Visual Analog Scale
Quality of life	2 years	Measured by SF-36 and atrial fibrillation symptoms and severity checklist
Exposure of radiation to health personnel involved in the procedure	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	Day 1	As a measure of pain and discomfort experienced by the patient during the procedure, the amount of medications are assessed
Procedure time	Day 1(after ablation procedure)	Duration of the ablation procedure
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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.
Numbers of and types of catheters used	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	During the procedure(Day 1)	Total time that electrical current has been used during the ablation
Cardiac volumes and function	1 year	Measured by echocardiography
Total time nurses are occupied with the ablation	During the ablation(day 1)	As a measure of cost and resources needed for the procedure
Myocardial damage	After ablation(day 1)	Measured by Troponin-t and CK-MBAs

Trial Locations

Locations (1)

Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway