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Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population (MAGNETIC-VT)

Primary Purpose

Tachycardia, Ventricular

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
catheter ablation using magnetic navigation
catheter ablation using manual navigation
Sponsored by
Stereotaxis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia, Ventricular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subject has had an ICD previously implanted
  • subject has drug-refractory monomorphic VT
  • subject is a candidate for ischemic VT RF ablation
  • subject has had a myocardial infarction
  • subject has a LVEF less than or equal to 35%

Exclusion Criteria:

  • subject has non-ischemic VT
  • subject has a history of stroke within 1 month prior to enrollment
  • subject has had an acute myocardial infarction within 30 days prior to enrollment
  • subject has unstable angina
  • subject has undergone cardiac surgery within 60 days prior to enrollment
  • subject is pregnant or nursing
  • subject has a limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.)
  • subject is unable or unwilling to cooperate with study procedures
  • subject has a known presence of intracardiac thrombi as determined by echocardiography
  • subject has a major contraindication to anticoagulation therapy or coagulation disorder
  • subject has had a previous pericarditis or cardiac tumor
  • subject has had previous thoracic radiation therapy
  • any other reason the investigator considers the subject ineligible

Sites / Locations

  • Florida Hospital
  • Augusta University
  • University of Chicago Medical Center
  • Advocate Christ Medical Center
  • The University of Kansas Medical Center
  • Weill Cornell Medical
  • Texas Cardiac Arrhythmia Research Foundation
  • Intermountain Heart Institute
  • Westmead Hospital
  • AZ Sint-Jan
  • ZNA Middelheim
  • Na Homolce Hospital
  • Rigshospitalet
  • Chu De Nancy - Hôpitaux De Brabois
  • Onze Lieve Vrouwe Gasthuis (OLVG)
  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magnetic navigation

Manual navigation

Arm Description

Catheter ablation using magnetic navigation for ventricular tachycardia via remote magnetic navigation of a NaviStar RMT ThermoCool catheter, or other magnetically compatible catheter, via Stereotaxis's Niobe ES system.

Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.

Outcomes

Primary Outcome Measures

freedom from any VT in the overall cohort

Secondary Outcome Measures

acute success of procedure
non-inducibility of clinical VT and/or other monomorphic VT using typical stimulation protocol for induction
freedom from VT in large scar subpopulation
major adverse events
death, cardiac tamponade, stroke, bleeding requiring surgical intervention, progressive heart failure related to VT/VF recurrence
mortality rate

Full Information

First Posted
December 4, 2015
Last Updated
September 23, 2022
Sponsor
Stereotaxis
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1. Study Identification

Unique Protocol Identification Number
NCT02637947
Brief Title
Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
Acronym
MAGNETIC-VT
Official Title
A Prospective, Multi-center, Post Market Randomized Controlled Trial Comparing VT Ablation Outcomes Using Remote MAGNETIC Navigation Guided Substrate Mapping and Ablation Versus Manual Approach in a Low LVEF Population
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
In the post-market environment, the RCT design did not allow achievement of enrollment goals
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stereotaxis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.
Detailed Description
This study is a randomized, single-blind, prospective, multi-center post market evaluation. Subjects will be screened for study eligibility and asked to complete written informed consent prior to any study specific testing assessments. After completing written informed consent, a total of 386 subjects will be randomized on a 1:1 basis to receive VT ablation treatment using either the Niobe ES or standard manual catheter ablation treatment using commercially available products. This will be the largest randomized VT study comparing outcomes from RMN to manually guided catheter ablation procedures. Subjects will be randomized according to a computer-generated randomization scheme. Randomization will be blocked at the study site level and subjects will be blinded to group assignment. Since quality of life measurements will be collected during follow-up, this study is single-blinded in order to mitigate patient bias. Clinical evaluations will not be masked to the treating physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic navigation
Arm Type
Experimental
Arm Description
Catheter ablation using magnetic navigation for ventricular tachycardia via remote magnetic navigation of a NaviStar RMT ThermoCool catheter, or other magnetically compatible catheter, via Stereotaxis's Niobe ES system.
Arm Title
Manual navigation
Arm Type
Active Comparator
Arm Description
Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.
Intervention Type
Device
Intervention Name(s)
catheter ablation using magnetic navigation
Intervention Description
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of Stereotaxis's Niobe ES System with the NaviStar RMT ThermoCool catheter or other magnetically compatible catheters.
Intervention Type
Device
Intervention Name(s)
catheter ablation using manual navigation
Intervention Description
elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of the NaviStar ThermoCool catheter or other manually navigated catheters.
Primary Outcome Measure Information:
Title
freedom from any VT in the overall cohort
Time Frame
12 months
Secondary Outcome Measure Information:
Title
acute success of procedure
Description
non-inducibility of clinical VT and/or other monomorphic VT using typical stimulation protocol for induction
Time Frame
at end of procedure (immediate)
Title
freedom from VT in large scar subpopulation
Time Frame
12 months
Title
major adverse events
Description
death, cardiac tamponade, stroke, bleeding requiring surgical intervention, progressive heart failure related to VT/VF recurrence
Time Frame
48 hours post-procedure
Title
mortality rate
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Total number of appropriate ICD defibrillator shocks
Time Frame
12 months
Title
Total number of ICD applications of anti-tachycardia pacing
Time Frame
12 months
Title
Total procedure time (skin to skin)
Time Frame
through end of acute procedure, an average of 3 hours
Title
Total fluoroscopy time
Time Frame
through end of acute procedure, an average of 3 hours
Title
Total fluoroscopy dose
Time Frame
through end of acute procedure, an average of 3 hours
Title
Total mapping time
Time Frame
through end of acute procedure, an average of 3 hours
Title
Total ablation time
Time Frame
through end of acute procedure, an average of 3 hours
Title
Total mapping points prior to ablation
Time Frame
through end of acute procedure, an average of 3 hours
Title
Total ablation energy delivery
Description
Watts X seconds / Total scar surface area
Time Frame
through end of acute procedure, an average of 3 hours
Title
Patient quality of life (SF-12)
Description
Medical Outcomes Study 12-item Short-Form Health Survey
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subject has had an ICD previously implanted subject has drug-refractory monomorphic VT subject is a candidate for ischemic VT RF ablation subject has had a myocardial infarction subject has a LVEF less than or equal to 35% Exclusion Criteria: subject has non-ischemic VT subject has a history of stroke within 1 month prior to enrollment subject has had an acute myocardial infarction within 30 days prior to enrollment subject has unstable angina subject has undergone cardiac surgery within 60 days prior to enrollment subject is pregnant or nursing subject has a limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.) subject is unable or unwilling to cooperate with study procedures subject has a known presence of intracardiac thrombi as determined by echocardiography subject has a major contraindication to anticoagulation therapy or coagulation disorder subject has had a previous pericarditis or cardiac tumor subject has had previous thoracic radiation therapy any other reason the investigator considers the subject ineligible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Weill Cornell Medical
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Intermountain Heart Institute
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
AZ Sint-Jan
City
Brugge
State/Province
West Flanders
ZIP/Postal Code
8000
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
Country
Belgium
Facility Name
Na Homolce Hospital
City
Praha
ZIP/Postal Code
15030
Country
Czechia
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Chu De Nancy - Hôpitaux De Brabois
City
Nancy
Country
France
Facility Name
Onze Lieve Vrouwe Gasthuis (OLVG)
City
Amsterdam
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
28064433
Citation
Di Biase L, Tung R, Szili-Torok T, Burkhardt JD, Weiss P, Tavernier R, Berman AE, Wissner E, Spear W, Chen X, Neuzil P, Skoda J, Lakkireddy D, Schwagten B, Lock K, Natale A; MAGNETIC VT investigators. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population. J Interv Card Electrophysiol. 2017 Apr;48(3):237-245. doi: 10.1007/s10840-016-0217-3. Epub 2017 Jan 7.
Results Reference
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Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population

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