NCT00560872

Brief Summary

The purpose of this study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

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

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

November 19, 2007

Last Update Submit

December 22, 2009

Conditions

Atrial Flutter

Keywords

atrial flutterablationnavigation

Outcome Measures

Primary Outcomes (1)

  • ablation duration and fluoroscopy time

    3 months

Secondary Outcomes (1)

  • total procedure duration, success, ablation characteristics, flutter recurrence, complications

    6 months

Study Arms (2)

1

OTHER

conventional ablation with manual catheter navigation

Procedure: cavotricuspid isthmus ablation

2

ACTIVE COMPARATOR

ablation with remote magnetic catheter navigation

Device: remote magnetic catheter navigation

Interventions

remote magnetic catheter navigationDEVICE

use of the Stereotaxis system

2
cavotricuspid isthmus ablationPROCEDURE

conventional (manual) approach

1

Eligibility Criteria

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

You may qualify if:

  • ECG documentation of at least 1 episode of typical atrial flutter

You may not qualify if:

  • Prior right atrial ablation
  • Ferromagnetic implants that may interfere with the magnetic navigation system
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet

Göttingen, 37075, Germany

Location

Related Publications (1)

  • Vollmann D, Luthje L, Seegers J, Hasenfuss G, Zabel M. Remote magnetic catheter navigation for cavotricuspid isthmus ablation in patients with common-type atrial flutter. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):603-10. doi: 10.1161/CIRCEP.109.884411.

    PMID: 20009074DERIVED

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dirk Vollmann, PD Dr. med.

    Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

DE(1)