Trial · NCT07904377
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of accurate post ablation outcome predictions Percentage of Accurate Post-Ablation Outcome Predictions | 12 Months | The ACORYS-AI4AF model will use non-invasive mapping data collected during standard clinical procedures to predict post-ablation outcomes. Accuracy will be reported as the percentage of predictions that correctly correspond with the observed post-ablation outcome. |
| Primary | Number of Patients to remain arrhythmia-free after pulmonary vein isolation (PVI) alone | 12 Months | Freedom from atrial fibrillation, atrial tachycardia, or atrial flutter lasting longer than 30 seconds, with or without symptoms, after a single ablation procedure (excluding episodes within the first 6 weeks post-procedure). This will be Measured through any of the following per standard of care procedures: 12-lead ECG, ambulatory rhythm monitoring devices, Consumer-facing wearable ECG devices (e.g., AliveCor KardiaMobile 6L, Apple Watch, etc), and Cardiac implanted electronic devices (implanted loop recorders, pacemakers, defibrillators). |
| Primary | Number of Patients not remaining arrhythmia-free after pulmonary vein isolation (PVI) and requiring additional atrial substrate ablation. | 12 Months | Freedom from atrial fibrillation, atrial tachycardia, or atrial flutter lasting longer than 30 seconds, with or without symptoms, after a single ablation procedure (excluding episodes within the first 6 weeks post-procedure). This will be Measured by the number of patients to undergo a second atrial substrate ablation post procedure. |
| Secondary | Percentage of patients with identified critical atrial regions contributing to arrhythmia maintenance for whom post-ablation outcomes were accurately predicted | 12 Months | Percentage of patients with identified critical atrial regions contributing to arrhythmia maintenance whose observed post-ablation outcome matched the outcome predicted based on the identified regions. Prediction accuracy is calculated as the proportion of correct predictions among all evaluated patients. |
| Secondary | Accuracy of Imageless Electrocardiographic Imaging (ECGI) in Identifying Arrhythmogenic Substrates | 12 Months | The accuracy of Imageless Electrocardiographic Imaging (ECGI) in identifying arrhythmogenic substrates will be assessed by comparison with conventional electroanatomical mapping. Accuracy will be reported as the percentage of ECGI findings that correspond with findings from conventional electroanatomical mapping. |
| Secondary | Percentage of procedures with successful mapping completed | 12 Months | Percentage of procedures with successful mapping completed will be determined by the findings that correspond with findings from conventional electroanatomical mapping. |
| Other | Number of Participants With Atrial Fibrillation Termination to Sinus Rhythm | Baseline | Number of participants with atrial fibrillation during the index catheter ablation procedure whose rhythm terminates to sinus rhythm during the procedure. |
| Other | Number of Participants With Atrial Fibrillation Conversion to Atrial Flutter | Baseline | Number of participants with atrial fibrillation during the index catheter ablation procedure whose rhythm converts to atrial flutter during the procedure. |
| Other | Radiation Exposure Time | Baseline | Duration of radiation exposure during the index catheter ablation procedure, reported in minutes. |
| Other | Total duration of index catheter ablation procedure | Baseline | Total duration of the index catheter ablation procedure measured in minutes |
| Other | Duration of ablation during procedure | Baseline | Total ablation time during the index catheter ablation procedure, reported in minutes. |
| Other | Number of participants with procedural complications | 12 Months | Number of participants experiencing at least one complication associated with the index catheter ablation procedure |
| Other | Number of serious adverse events | 12 Months | The number of serious adverse events (SAEs), including unanticipated adverse device effects, will be measured as the total number of events reported during the study. |
| Other | Number of device failures | 12 Months | The number of device failures, including device malfunctions, will be measured as the total number of events reported throughout the study. |
| Other | Number of skin irritation reactions | 12 Months | The number of skin irritation reactions will be measured as the total number of events reported throughout the study. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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