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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02637947




Registration number
NCT02637947
Ethics application status
Date submitted
4/12/2015
Date registered
22/12/2015
Date last updated
17/03/2020

Titles & IDs
Public title
Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
Scientific 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
Secondary ID [1] 0 0
CLIN-021
Universal Trial Number (UTN)
Trial acronym
MAGNETIC-VT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tachycardia, Ventricular 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - catheter ablation using magnetic navigation
Treatment: Devices - catheter ablation using manual navigation

Experimental: Magnetic navigation - 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.

Active Comparator: Manual navigation - Catheter ablation using manual navigation for ventricular tachycardia via a manually navigated Thermocool catheter, or equivalent catheter.


Treatment: Devices: catheter ablation using magnetic navigation
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.

Treatment: Devices: catheter ablation using manual navigation
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
freedom from any VT in the overall cohort
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
acute success of procedure - non-inducibility of clinical VT and/or other monomorphic VT using typical stimulation protocol for induction
Timepoint [1] 0 0
at end of procedure (immediate)
Secondary outcome [2] 0 0
freedom from VT in large scar subpopulation
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
major adverse events - death, cardiac tamponade, stroke, bleeding requiring surgical intervention, progressive heart failure related to VT/VF recurrence
Timepoint [3] 0 0
48 hours post-procedure
Secondary outcome [4] 0 0
mortality rate
Timepoint [4] 0 0
12 months

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
Belgium
State/province [8] 0 0
West Flanders
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Czechia
State/province [10] 0 0
Praha
Country [11] 0 0
Denmark
State/province [11] 0 0
Copenhagen
Country [12] 0 0
France
State/province [12] 0 0
Nancy
Country [13] 0 0
Netherlands
State/province [13] 0 0
Amsterdam
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Stereotaxis
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the
Niobeā„¢ ES system results in superior outcomes compared to a manual approach in subjects with
ischemic scar VT in a low ejection fraction population.
Trial website
https://clinicaltrials.gov/show/NCT02637947
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrea Natale, MD
Address 0 0
Texas Cardiac Arrhythmia Research Foundation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ken Lock
Address 0 0
Country 0 0
Phone 0 0
13146786123
Fax 0 0
Email 0 0
ken.lock@stereotaxis.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02637947