NCT01407588

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

5.5 years

First QC Date

June 8, 2011

Last Update Submit

March 15, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationAblation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Procedure time

    Day 1(after ablation procedure)

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

    Day 1(after ablation procedure)

  • Exposure of radiation to health personnel involved in the procedure

    Day 1(after ablation procedure)

  • Amount of analgetics and sedatives given during procedure

    Day 1

  • Pain

    After ablation(day 1)

  • +6 more secondary outcomes

Study Arms (2)

Magnetic navigation

EXPERIMENTAL
Procedure: Magnetic navigation

Manual navigation

EXPERIMENTAL
Procedure: Ablation performed with manual navigation

Interventions

Magnetic navigationPROCEDURE

Ablation with use of the magnetic navigation system

Magnetic navigation
Ablation performed with manual navigationPROCEDURE

Atrial fibrillation ablation performed with manual navigation

Manual navigation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Norway

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jan Paal Loennechen, PhD

    St. Olavs Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2011

First Posted

August 2, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 16, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)