Ventricular Tachycardia Clinical Trial
— STOP-VTOfficial title:
Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia: Data Collection of Clinical Scar-related VT Cases
This is a prospective, non-randomized, multi-center clinical case series evaluating the outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects will be evaluated acutely and will be followed clinically at 1, 6 and 12 months post-treatment.
Status | Completed |
Enrollment | 53 |
Est. completion date | April 2013 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Subject must be between the ages of 18 - 80 years - Willing to provide prior written informed consent per local ethics committee guidelines - Subjects must present with ventricular tachycardia, characterized by: history of myocardial scar and spontaneous ventricular tachycardia - Able to be safely exposed to static magnetic fields - No in-situ devices are present or any in-situ devices have been verified to be compatible to magnetic fields Exclusion Criteria: - Presence of a mobile ventricular thrombus - Inability to access the left ventricle - Subjects must not have any contraindications to short-term anticoagulation - Subjects must not have a life expectancy of <1 year due to a medical illness |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Czech Republic | Na Homolce Hospital | Prague | |
Germany | Herzzentrum Universitat Leipzig | Leipzig | |
United States | Krannert Institute of Cardiology | Indianapolis | Indiana |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Stereotaxis |
United States, Czech Republic, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Free From VT at 1 Year Post-Treatment | In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy. | 1 Year follow-up | No |
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