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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:January 2016
End Date:December 2022
Contact:Ken Lock
Email:ken.lock@stereotaxis.com
Phone:13146786123

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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

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.

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.

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
We found this trial at
9
sites
Westmead, New South Wales 2145
Principal Investigator: Pramesh Kovoor, MD, PhD
Phone: (02) 8890 4719
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Augusta, Georgia 30912
Principal Investigator: Adam Berman, MD
Phone: 706-721-0193
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Augusta, GA
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Austin, Texas 78758
Principal Investigator: Andrea Natale, MD
Phone: 512-458-9410
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Austin, TX
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Roderick Tung, MD
Phone: 773-702-0535
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Dhanunjaya Lakkireddy, M.D.
Phone: 913-945-6443
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Murray, Utah 84143
Principal Investigator: J. Peter Weiss, MD
Phone: 801-507-4722
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Murray, UT
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1300 York Avenue
New York, New York 10065
Principal Investigator: Jim W Cheung, MD
Phone: 646-962-8493
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New York, NY
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Phone: 708-684-4522
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Oak Lawn, IL
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Usman Siddiqui, M.D.
Phone: 407-303-8059
Florida Hospital Florida Hospital is one of the country
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Orlando, FL
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