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

Tachycardia, Ventricular Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02637947
• Other study ID #: CLIN-021
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 15, 2022

Study information

• Verified date: September 2022
• Source: Stereotaxis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 182
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	ZNA Middelheim	Antwerpen
Belgium	AZ Sint-Jan	Brugge	West Flanders
Czechia	Na Homolce Hospital	Praha
Denmark	Rigshospitalet	Copenhagen
France	Chu De Nancy - Hôpitaux De Brabois	Nancy
Netherlands	Onze Lieve Vrouwe Gasthuis (OLVG)	Amsterdam
Netherlands	Erasmus Medical Center	Rotterdam
United States	Augusta University	Augusta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	University of Chicago Medical Center	Chicago	Illinois
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Intermountain Heart Institute	Murray	Utah
United States	Weill Cornell Medical	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Florida Hospital	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Stereotaxis

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Czechia,  Denmark,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total number of appropriate ICD defibrillator shocks		12 months
Other	Total number of ICD applications of anti-tachycardia pacing		12 months
Other	Total procedure time (skin to skin)		through end of acute procedure, an average of 3 hours
Other	Total fluoroscopy time		through end of acute procedure, an average of 3 hours
Other	Total fluoroscopy dose		through end of acute procedure, an average of 3 hours
Other	Total mapping time		through end of acute procedure, an average of 3 hours
Other	Total ablation time		through end of acute procedure, an average of 3 hours
Other	Total mapping points prior to ablation		through end of acute procedure, an average of 3 hours
Other	Total ablation energy delivery	Watts X seconds / Total scar surface area	through end of acute procedure, an average of 3 hours
Other	Patient quality of life (SF-12)	Medical Outcomes Study 12-item Short-Form Health Survey	12 months
Primary	freedom from any VT in the overall cohort		12 months
Secondary	acute success of procedure	non-inducibility of clinical VT and/or other monomorphic VT using typical stimulation protocol for induction	at end of procedure (immediate)
Secondary	freedom from VT in large scar subpopulation		12 months
Secondary	major adverse events	death, cardiac tamponade, stroke, bleeding requiring surgical intervention, progressive heart failure related to VT/VF recurrence	48 hours post-procedure
Secondary	mortality rate		12 months