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| Name | Class |
|---|---|
| Experien Group | UNKNOWN |
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This is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping system (vMapâ„¢).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac ablation procedure | Device | Retrospective data will be collected from cases where successful ablation was completed. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of accuracy/agreement of vMapâ„¢ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT. | Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of accuracy/agreement of vMapâ„¢ in correctly identifying the chamber/region of the arrhythmia location for all arrhythmia types. | Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria. | |
| Rate of accuracy/agreement of vMapâ„¢ in correctly identifying the segment of the arrhythmia treatment across all arrhythmia types. |
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Inclusion Criteria:
Patient has one of the following clinical arrhythmia/pacing types:
Patient has undergone 'successful' routine, standard of care diagnostic electrophysiology (EP) study using intracardiac catheters as clinically indicated, guided by fluoroscopy and routine electroanatomic mapping, intracardiac echocardiography, and/or cardiac imaging such as CT or MRI.
Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.
Patient has undergone a successful ablation procedure.
Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.
Patient was between 22 and 100 years of age at time of EP study and ablation procedure.
Exclusion Criteria:
Patients with unstable coronary artery disease, confirmed intracardiac thrombus, active sepsis, complex congenital heart disease, dextrocardia, severe pulmonary hypertension, decompensated heart failure, a mechanical heart valve, myocardial infarction within 1 month of ablation, inability to induce arrhythmia, unacceptable ECG data quality, and/or data included in the device training dataset.
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Adult patients with cardiac arrhythmia that have undergone successful ablation procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Chris Villongco, PhD | Vektor Medical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | California | 29425 | United States | ||
| University of California San Diego Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36069189 | Derived | 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 23, 2021 | |
| Reset | Jan 31, 2022 | |
| Release | Oct 17, 2022 |
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| Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria. |
| La Jolla |
| California |
| 92093 |
| United States |
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
| Sutter Health | San Francisco | California | 94107 | United States |
| Reset | Aug 30, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 23, 2021 | Jan 31, 2022 | |||
| Oct 17, 2022 | Aug 30, 2023 |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D018880 | Atrial Premature Complexes |
| D013611 | Tachycardia, Atrioventricular Nodal Reentry |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D005117 | Cardiac Complexes, Premature |
| D054139 | Tachycardia, Reciprocating |
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