NCT00875914

Brief Summary

The MAGMA-AVNRT study compares two different methods of handling the ablation catheters for av-node-reentry-tachycardia with regard to x-ray dose, safety and success: manually guided vs magnetically navigated RF-catheter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4

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

Study Start

First participant enrolled

April 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

2.9 years

First QC Date

April 3, 2009

Last Update Submit

June 24, 2016

Conditions

Atrioventricular Nodal Reentry TachycardiaRadiofrequency Ablation

Keywords

AV-node reentry tachycardiaradiofrequency ablationmagnetic navigation system

Outcome Measures

Primary Outcomes (1)

  • Total x-ray time and dose for patient

    electrophysiological examination

Secondary Outcomes (5)

  • X-ray time and dose for physician

    electrophysiological study

  • Safety of ablation (AV-Block, perforation)

    end of electrophysiological study

  • short-term and long-term-success

    end of procedure and 6 months after procedure

  • number of RF-application

    procedure

  • Duration of electrophysiological study (ablation included)

    procedure

Study Arms (2)

Manually guided

EXPERIMENTAL

Treatment with manually guided RF-catheter

Procedure: RF-ablation

Magnetically navigated

EXPERIMENTAL

Treatment with magnetically navigated RF-catheter.

Procedure: RF-ablation

Interventions

RF-ablationPROCEDURE

4mm-tip catheter manually guided vs magneticallly navigated

Magnetically navigatedManually guided

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 years old
  • suspected AV-node-reentry-tachycardia
  • written informed consent

You may not qualify if:

  • pregnancy
  • contraindication against electrophysiological study or ablation
  • congenital heart disease or other anatomical abnormalities
  • previous surgical procedure involving atrium except aorto-coronary bypass grafts
  • psychiatric disease that makes a completion of study improbable
  • severe comorbidities with a life expectancy less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bergen

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

Tachycardia, ReciprocatingTachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gabi Hessling, MD

    Deutsches Herzzentrum München

    STUDY CHAIR

  • Peter Schuster, MD

    University of Bergen

    STUDY CHAIR

  • Isabel Deisenhofer, MD

    Deutsches Herzzentrum München

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2012

Study Completion

October 1, 2012

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

NO(1)