Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatments magnetic navigation, ablation performed with manual navigation
Sponsor Norwegian University of Science and Technology
Collaborator St. Olavs Hospital
Start date August 2011
End date November 2016
Trial size 50 participants
Trial identifier NCT01407588, 2010/3345-2

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
magnetic navigation
Ablation with use of the magnetic navigation system
(Experimental)
ablation performed with manual navigation
Atrial fibrillation ablation performed with manual navigation

Primary Outcomes

Measure
Number of participants with recurrence of atrial fibrillation after ablation
time frame: 2 years

Secondary Outcomes

Measure
Procedure time
time frame: Day 1(after ablation procedure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Day 1(after ablation procedure)
Exposure of radiation to health personnel involved in the procedure
time frame: Day 1(after ablation procedure)
Amount of analgetics and sedatives given during procedure
time frame: Day 1
Pain
time frame: After ablation(day 1)
Numbers of and types of catheters used
time frame: During ablation(Day1)
Time with active ablation
time frame: During the procedure(Day 1)
Total time nurses are occupied with the ablation
time frame: During the ablation(day 1)
Myocardial damage
time frame: After ablation(day 1)
Cardiac volumes and function
time frame: 1 year
Quality of life
time frame: 2 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Undergoing ablation for atrial fibrillation at St. Olavs Hospital - Implanted Reveal

Additional Information

Official title Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.