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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Magnetic navigation; Procedure: Ablation performed with manual navigation

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • Norwegian University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; SINTEF Health Research
• Investigators: Study Chair: Jan Paal Loennechen, PhD, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: August 1, 2011
• First Posted (Estimate): August 2, 2011

Study Record Updates

• Last Update Posted (Actual): March 16, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2010/3345-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No