- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00851279
Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia (STOP-VT)
Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia: Data Collection of Clinical Scar-related VT Cases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Catheter ablation of ventricular tachycardia (VT) is greatly facilitated by using a substrate mapping approach - that is, mapping of the left ventricle during sinus or paced rhythm to identify diseased myocardium. Using three dimensional electroanatomical mapping, it is possible to reconstruct an anatomical rendering of the left ventricle based on voltage. For hemodynamically stable or unstable VTs, various electrophysiologic maneuvers can then be used to identify the critical portions of the VT circuit within the scar (entrainment mapping, identification of diastolic potentials, identification of electrically-unexcitable scar, fractionated potentials and pace mapping).
These methods are limited by the resolution of the substrate map, accuracy of catheter manipulation, and operator skill. To this end, a magnetic navigation system has been developed that allows for remote cardiac mapping. When used in concert with a compatible electroanatomical mapping system, it is possible to create a high-density ventricular substrate map of healed myocardial infarction. By removing the necessity for technical skill with catheter manipulation, this system has the potential for both improving the efficacy of VT ablation and expanding the clinical use of this substrate mapping approach.
Recently, a higher-powered, irrigated tip catheter has become available in certain markets for use in cardiac arrhythmia ablations. This study will evaluate the outcomes of using this magnetic irrigation ablation catheter during mapping and ablation of VT while also using remote magnetic navigation.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Prague, Czech Republic, 15630
- Na Homolce Hospital
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Leipzig, Germany, 04289
- Herzzentrum Universität Leipzig
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Indiana
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Indianapolis, Indiana, United States, 46202
- Krannert Institute of Cardiology
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Magnetic irrigated ablation catheter
Patients with documented VT and prior MI, in whom an ICD was implanted either for primary or secondary prevention, were recruited for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with remote magnetic navigation (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
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Magnetic irrigated catheter to be used with the magnetic navigation system
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Free From VT at 1 Year Post-Treatment
Time Frame: 1 Year follow-up
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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.
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1 Year follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Petr Neuzil, MD, Na Homolce Hospital, Prague, CZ
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PM-CLIN-013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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