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The purpose of this study is to evaluate the clinical outcomes (clinical efficacy and safety) of using supplemental non-invasive computational ECG and cardiac imaging analysis tools to help guide ablation of ventricular tachycardia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VT ablation guided by supplemental non-invasive computational imaging analysis | Experimental | The electrophysiologist performing the standard-of-care VT ablation will have access to supplemental arrhythmia targeting/localization information provided by computational non-invasive ECG and/or cardiac CT imaging analysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computational electrocardiography and cardiac computed tomography mapping | Diagnostic Test | Use of non-invasive computational ECG and cardiac CT models to localize arrhythmia origins |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent ventricular tachycardia | Ventricular tachycardia episodes defined as implantable cardioverter defibrillator (ICD) therapies (anti-tachycardia pacing and shocks) | 1 year |
| All-cause death | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Acute hemodynamic decompensation | acute development of hypotension, cardiogenic shock, escalation of inotropes/pressors, or need for unplanned percutaneous hemodynamic support | 24 hours post-op |
| Unplanned prolonged ICU upgrade |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Health | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36069189 | Background | Krummen DE, Villongco CT, Ho G, Schricker AA, Field ME, Sung K, Kacena KA, Martinson MS, Hoffmayer KS, Hsu JC, Raissi F, Feld GK, McCulloch AD, Han FT. Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study. Circ Arrhythm Electrophysiol. 2022 Sep;15(9):e010857. doi: 10.1161/CIRCEP.122.010857. Epub 2022 Sep 7. |
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Limited de-identified clinical datasets may be shared upon individual request
1/1/2029-12/31/2032
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In outpatient elective cases, change in patient condiction neccessitating unplanned ICU upgrade lasting longer than 48 hours.
| 48 hours |
| acute cerebrovascular accident (embolic) | 24 hours post-op |
| acute pericardial tamponade requiring intervention | new expanding hemorrhagic pericardial effusion causing tamponade requiring urgent pericardiocentesis | 24 hours post-op |
| vascular complication requiring intervention | vascular access complication (bleeding or occlusion) requiring blood transfusion or vascular procedure (such as peripheral angioplasty) | 24 hours post-op |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D018879 | Ventricular Premature Complexes |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005117 | Cardiac Complexes, Premature |
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