Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
Conditions
Keywords
Atrium, tachyarrhythmias
Brief summary
This study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTNo Intervention. Test is computer algorithm.
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
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing catheter ablation for atrial arrhythmias
Exclusion criteria
* Inability to sign informed consent * Expected survival \< 1 year * Extreme comorbidity, such as advanced NYHA Class III/IV heart failure, dialysis, series stroke.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in AF burden on follow-up | 2 years | Reduction in amount of arrhythmia per unit time, compared to prior to the procedure. |
| Freedom from arrhythmia on follow-up | 2 years | Absence of arrhythmia, defined by clinical thresholds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical status as measured by the EQ5D | 2 years | Patient feeling better subjectively in EQ5D |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acute Impact of Ablation | Day zero (that is, during procedure). | Documentation of whether ablation acutely eliminated atrial fibrillation |
Countries
United States
Outcome results
None listed