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OpenTrials
Completed

NCT Number: NCT01407588

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian University of Science and Technology

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Magnetic navigation

Procedure

Ablation with use of the magnetic navigation system

Ablation performed with manual navigation

Procedure

Atrial fibrillation ablation performed with manual navigation

Primary outcomes

  1. Number of participants with recurrence of atrial fibrillation after ablation

    Time frame: 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 outcomes

  1. Procedure time

    Time frame: Day 1(after ablation procedure)

    Duration of the ablation procedure

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 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.

  3. Exposure of radiation to health personnel involved in the procedure

    Time frame: Day 1(after ablation procedure)

    Total time with use of of radiation equipment. Radiation exposure of the operator.

  4. Amount of analgetics and sedatives given during procedure

    Time frame: Day 1

    As a measure of pain and discomfort experienced by the patient during the procedure, the amount of medications are assessed

  5. Pain

    Time frame: After ablation(day 1)

    Pain scores on the Visual Analog Scale

  6. Numbers of and types of catheters used

    Time frame: 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.

  7. Time with active ablation

    Time frame: During the procedure(Day 1)

    Total time that electrical current has been used during the ablation

  8. Total time nurses are occupied with the ablation

    Time frame: During the ablation(day 1)

    As a measure of cost and resources needed for the procedure

  9. Myocardial damage

    Time frame: After ablation(day 1)

    Measured by Troponin-t and CK-MBAs

  10. Cardiac volumes and function

    Time frame: 1 year

    Measured by echocardiography

  11. Quality of life

    Time frame: 2 years

    Measured by SF-36 and atrial fibrillation symptoms and severity checklist

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • SINTEF Health Research
  • St. Olavs Hospital

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2011
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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