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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic irrigated ablation catheter | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic irrigated ablation catheter | Device | Magnetic irrigated catheter to be used with the magnetic navigation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petr Neuzil, MD | Na Homolce Hospital, Prague, CZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krannert Institute of Cardiology | Indianapolis | Indiana | 46202 | United States | ||
| Hospital of the University of Pennsylvania |
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| Label | URL |
|---|---|
| Study Sponsor | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnetic Irrigated Ablation Catheter | Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnetic Irrigated Ablation Catheter | Patients underwent ablation therapy using remote magnetic navigation, RMN (Niobe, Stereotaxis Inc.,St Louis, USA), and an irrigated RF ablation catheter (NaviStar RMT ThermoCool, Biosense Webster,California, USA). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants free from VT | 1 Year follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnetic Irrigated Ablation Catheter | Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system There were no adverse events associated with the procedure and within a 7 to 10 days post-doc window |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Qun Sha, MD, Director of Clinical Trials | Stereotaxis Inc. | 314 678 6143 | qun.sha@stereotaxis.com |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Na Homolce Hospital | Prague | 15630 | Czechia |
| Herzzentrum Universitat Leipzig | Leipzig | 04289 | Germany |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Left Ventricular Ejection Fraction | Mean | Inter-Quartile Range | percent |
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| History of cerebro-vascular accident (CVA) | Number | participants |
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| History of transient ischemic attack (TIA) | Number | participants |
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| History of diabetes | Number | participants |
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| Pre-procedural arrhythmia treatment with beta-blockers | Number | participants |
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| Pre-procedural arrhythmia treatment with amiodarone | Number | participants |
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| ICD implanted prior to the ablation procedure | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 53 |
| 0 |
| 53 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |