Clinical trial NCT02637947: Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
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
Overall status: TERMINATED
Phase: NA
Conditions: Tachycardia, Ventricular
Lead sponsor: Stereotaxis
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: freedom from any VT in the overall cohort
timeFrame: 12 months
Secondary outcomes:
measure: acute success of procedure
timeFrame: at end of procedure (immediate)
measure: freedom from VT in large scar subpopulation
timeFrame: 12 months
measure: major adverse events
timeFrame: 48 hours post-procedure
measure: mortality rate
timeFrame: 12 months
Other outcomes:
measure: Total number of appropriate ICD defibrillator shocks
timeFrame: 12 months
measure: Total number of ICD applications of anti-tachycardia pacing
timeFrame: 12 months
measure: Total procedure time (skin to skin)
timeFrame: through end of acute procedure, an average of 3 hours
measure: Total fluoroscopy time
timeFrame: through end of acute procedure, an average of 3 hours
measure: Total fluoroscopy dose
timeFrame: through end of acute procedure, an average of 3 hours
measure: Total mapping time
timeFrame: through end of acute procedure, an average of 3 hours
measure: Total ablation time
timeFrame: through end of acute procedure, an average of 3 hours
measure: Total mapping points prior to ablation
timeFrame: through end of acute procedure, an average of 3 hours
measure: Total ablation energy delivery
timeFrame: through end of acute procedure, an average of 3 hours
measure: Patient quality of life (SF-12)
timeFrame: 12 months
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: New York
country: United States
facility: Weill Cornell Medical
state: New York
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Murray
country: United States
facility: Intermountain Heart Institute
state: Utah
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brugge
country: Belgium
facility: AZ Sint-Jan
state: West Flanders
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Praha
country: Czechia
facility: Na Homolce Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Nancy
country: France
facility: Chu De Nancy - Hôpitaux De Brabois
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis (OLVG)
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.