Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

December 22, 2009 updated by: University Hospital Goettingen

Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Goettingen, Germany, 37075
        • Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
conventional ablation with manual catheter navigation
Procedure: cavotricuspid isthmus ablation
conventional (manual) approach
ACTIVE_COMPARATOR: 2
ablation with remote magnetic catheter navigation
Device: remote magnetic catheter navigation
use of the Stereotaxis system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ablation duration and fluoroscopy time
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
total procedure duration, success, ablation characteristics, flutter recurrence, complications
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Goettingen

Collaborators

Stereotaxis

Investigators

  • Principal Investigator: Dirk Vollmann, PD Dr. med., Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (ESTIMATE)

November 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 22, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MN-07-022-GOE
  • Stereotaxis#07-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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