Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
St. Olavs Hospital
SINTEF Health Research
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01407588
First received: June 8, 2011
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Atrial Fibrillation
Procedure: Magnetic navigation
Procedure: Ablation performed with manual navigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Number of participants with recurrence of atrial fibrillation after ablation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Procedure time [ Time Frame: Day 1(after ablation procedure) ] [ Designated as safety issue: No ]
    Duration of the ablation procedure

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 1(after ablation procedure) ] [ Designated as safety issue: No ]
    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.

  • Exposure of radiation to health personnel involved in the procedure [ Time Frame: Day 1(after ablation procedure) ] [ Designated as safety issue: No ]
    Total time with use of of radiation equipment. Radiation exposure of the operator.

  • Amount of analgetics and sedatives given during procedure [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    As a measure of pain and discomfort experienced by the patient during the procedure, the amount of medications are assessed

  • Pain [ Time Frame: After ablation(day 1) ] [ Designated as safety issue: No ]
    Pain scores on the Visual Analog Scale

  • Numbers of and types of catheters used [ Time Frame: During ablation(Day1) ] [ Designated as safety issue: No ]
    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 [ Time Frame: During the procedure(Day 1) ] [ Designated as safety issue: No ]
    Total time that electrical current has been used during the ablation

  • Total time nurses are occupied with the ablation [ Time Frame: During the ablation(day 1) ] [ Designated as safety issue: No ]
    As a measure of cost and resources needed for the procedure

  • Myocardial damage [ Time Frame: After ablation(day 1) ] [ Designated as safety issue: No ]
    Measured by Troponin-t and CK-MBAs


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing ablation for atrial fibrillation at St. Olavs Hospital
  • Implanted Reveal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407588

Locations
Norway
Norwegian University of Science and Technology
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
SINTEF Health Research
Investigators
Study Chair: Jan Paal Loennechen, PhD St. Olavs Hospital
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01407588     History of Changes
Other Study ID Numbers: 2010/3345-2
Study First Received: June 8, 2011
Last Updated: June 20, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Norwegian University of Science and Technology:
Atrial fibrillation
Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014