NCT00851279

Brief Summary

This is a prospective, non-randomized, multi-center clinical case series evaluating the outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects will be evaluated acutely and will be followed clinically at 1, 6 and 12 months post-treatment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_4

Geographic Reach
3 countries

4 active sites

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

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

August 24, 2015

Completed
Last Updated

August 24, 2015

Status Verified

July 1, 2015

Enrollment Period

3.3 years

First QC Date

February 24, 2009

Results QC Date

December 2, 2013

Last Update Submit

July 27, 2015

Conditions

Ventricular Tachycardia

Keywords

arrhythmiaventricular tachycardiaablationmappingelectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Free From VT at 1 Year Post-Treatment

    In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.

    1 Year follow-up

Study Arms (1)

Magnetic irrigated ablation catheter

EXPERIMENTAL

Patients with documented VT and prior MI, in whom an ICD was implanted either for primary or secondary prevention, were recruited for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with remote magnetic navigation (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).

Device: Magnetic irrigated ablation catheter

Interventions

Magnetic irrigated ablation catheterDEVICE

Magnetic irrigated catheter to be used with the magnetic navigation system

Also known as: Niobe, Stereotaxis, Navigant
Magnetic irrigated ablation catheter

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be between the ages of 18 - 80 years
  • Willing to provide prior written informed consent per local ethics committee guidelines
  • Subjects must present with ventricular tachycardia, characterized by: history of myocardial scar and spontaneous ventricular tachycardia
  • Able to be safely exposed to static magnetic fields
  • No in-situ devices are present or any in-situ devices have been verified to be compatible to magnetic fields

You may not qualify if:

  • Presence of a mobile ventricular thrombus
  • Inability to access the left ventricle
  • Subjects must not have any contraindications to short-term anticoagulation
  • Subjects must not have a life expectancy of \<1 year due to a medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Na Homolce Hospital

Prague, 15630, Czechia

Location

Herzzentrum Universitat Leipzig

Leipzig, 04289, Germany

Location

Related Links

MeSH Terms

Conditions

Tachycardia, VentricularArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

TachycardiaHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Qun Sha, MD, Director of Clinical Trials
Organization
Stereotaxis Inc.
qun.sha@stereotaxis.com
314 678 6143

Study Officials

  • Petr Neuzil, MD

    Na Homolce Hospital, Prague, CZ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2012

Study Completion

April 1, 2013

Last Updated

August 24, 2015

Results First Posted

August 24, 2015

Record last verified: 2015-07

Locations

CZ(1)DE(1)US(2)