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This study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias.
Patients will be recruited prospectively from among those undergoing ablation for atrial fibrillation (AF) or atrial tachycardias (AT) which may be reentrant or focal. Each patient will undergo careful data collection, including electrogram data and sites of ablation lesions. Ablation will proceed in operator-dependent fashion, and will not be modified in any way for this study. The research question is whether algorithms based on data such as electrograms and details of the ablation performed can predict which patients will have a successful case. Primary endpoints are measures of clinical success defined by (a) acute termination of atrial arrhythmia during the case; (b) long-term reduction in arrhythmia burden; (c) long-term freedom from arrhythmia. Secondary endpoints include (a) identification of sites of arrhythmia termination; (b) improved clinical status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Cohort | No study intervention. Patients referred for ablation of atrial arrhythmias will be treated as per operator preference with no study intervention. Data will be collected in de-identified fashion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention. Test is computer algorithm. | Diagnostic Test | Diagnostic algorithms (test) will be run on already acquired clinical data. No study intervention in operator-prescribed clinical ablation. Predictive accuracy of test for study outcome will then be determined in follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in AF burden on follow-up | Reduction in amount of arrhythmia per unit time, compared to prior to the procedure. | 2 years |
| Freedom from arrhythmia on follow-up | Absence of arrhythmia, defined by clinical thresholds. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical status as measured by the EQ5D | Patient feeling better subjectively in EQ5D | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Impact of Ablation | Documentation of whether ablation acutely eliminated atrial fibrillation | Day zero (that is, during procedure). |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing clinically prescribed ablation for complex atrial arrhythmias will be approached for enrollment. Most are anticipated to be atrial fibrillation or atrial tachyarrhythmias such as post-ablation flutter. Men and women over 21 years and up to 80 years of age will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Sanjiv Narayan, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28185348 | Result | Alhusseini M, Vidmar D, Meckler GL, Kowalewski CA, Shenasa F, Wang PJ, Narayan SM, Rappel WJ. Two Independent Mapping Techniques Identify Rotational Activity Patterns at Sites of Local Termination During Persistent Atrial Fibrillation. J Cardiovasc Electrophysiol. 2017 Jun;28(6):615-622. doi: 10.1111/jce.13177. Epub 2017 Mar 20. | |
| 29330332 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D001145 | Arrhythmias, Cardiac |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Zaman JAB, Sauer WH, Alhusseini MI, Baykaner T, Borne RT, Kowalewski CAB, Busch S, Zei PC, Park S, Viswanathan MN, Wang PJ, Brachmann J, Krummen DE, Miller JM, Rappel WJ, Narayan SM, Peters NS. Identification and Characterization of Sites Where Persistent Atrial Fibrillation Is Terminated by Localized Ablation. Circ Arrhythm Electrophysiol. 2018 Jan;11(1):e005258. doi: 10.1161/CIRCEP.117.005258. |
| 29214421 | Result | Sahli Costabal F, Zaman JAB, Kuhl E, Narayan SM. Interpreting Activation Mapping of Atrial Fibrillation: A Hybrid Computational/Physiological Study. Ann Biomed Eng. 2018 Feb;46(2):257-269. doi: 10.1007/s10439-017-1969-3. Epub 2017 Dec 6. |
| 29377478 | Result | Navara R, Leef G, Shenasa F, Kowalewski C, Rogers AJ, Meckler G, Zaman JAB, Baykaner T, Park S, Turakhia MP, Zei P, Viswanathan M, Wang PJ, Narayan SM. Independent mapping methods reveal rotational activation near pulmonary veins where atrial fibrillation terminates before pulmonary vein isolation. J Cardiovasc Electrophysiol. 2018 May;29(5):687-695. doi: 10.1111/jce.13446. Epub 2018 Feb 22. |
| D000075224 | Cardiac Conduction System Disease |