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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2022 |
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Main ID: |
NCT02637947 |
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Date of registration:
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04/12/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population
MAGNETIC-VT |
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Scientific title:
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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 |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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182 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02637947 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Australia
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Belgium
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Czech Republic
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Czechia
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Denmark
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France
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Netherlands
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United States
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Contacts
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Name:
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Andrea Natale, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Texas Cardiac Arrhythmia Research Foundation |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tachycardia, Ventricular
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Intervention(s)
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Device: catheter ablation using magnetic navigation
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Device: catheter ablation using manual navigation
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Primary Outcome(s)
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freedom from any VT in the overall cohort
[Time Frame: 12 months]
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Secondary Outcome(s)
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major adverse events
[Time Frame: 48 hours post-procedure]
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acute success of procedure
[Time Frame: at end of procedure (immediate)]
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mortality rate
[Time Frame: 12 months]
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freedom from VT in large scar subpopulation
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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