Trial · NCT07899918
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Between-group difference in atrial-arrhythmia burden | From the end of the 8-week blanking period through 12 months and before any crossover ablation | Between-group difference in atrial-arrhythmia burden, defined as the percentage of analyzable ILR time spent in atrial arrhythmia, measured during off-AAD intervals from the end of the 8-week blanking period through 12 months and before any crossover ablation, comparing PV re-isolation plus Marshall-plan strategy versus PV re-isolation alone. |
| Secondary | Number of Participants with Freedom from Atrial Arrhythmia after 1 Ablation Procedure without Antiarrhythmic Drugs (AAD) | From the end of the 8-week blanking period through 12 months and before any crossover ablation | 1\. Freedom from AF/AT/AFL ≥30 s at 12 months (after 8-week blanking period), centrally adjudicated |
| Secondary | Arrhythmia burden during off-AAD follow-up time and before any crossover ablation | From the end of the 8-week blanking period through 12 months and before any crossover ablation | Arrhythmia burden during off-AAD follow-up time and before any crossover ablation, with additional sensitivity analyses accounting for DC cardioversion and repeat ablation. |
| Secondary | Arrhythmia burden between groups in patients on AAD | From the end of the 8-week blanking period through 12 months and before any crossover ablation | |
| Secondary | Between-group difference in atrial-arrhythmia burden, percent of analyzable time in AF/AT/AFL by ILR measured irrespective of the AAD use | From the end of the blanking period (week 8) through 12 months, comparing PV re-isolation + Marshall-plan vs PV re-isolation only. | |
| Secondary | Differences in arrhythmia burden without blanking period. | Through 12 months, comparing PV re-isolation + Marshall-plan vs PV re-isolation only. | |
| Secondary | Total procedure time | During the index procedure | |
| Secondary | Total fluoroscopy time | During the index procedure | |
| Secondary | Freedom from DC cardioverted atrial arrhythmia | At 6 and 12 months | |
| Secondary | Freedom from atrial fibrillation | At 6 and 12 months | |
| Secondary | Number of DC-cardioverted atrial arrhythmia | From the end of the blanking period (week 8) through 12 months, comparing PV re-isolation + Marshall-plan vs PV re-isolation only. | |
| Secondary | Burden analysis adjusted for the number of post-blanking DC cardioversions | From the end of the blanking period (week 8) through 12 months, comparing PV re-isolation + Marshall-plan vs PV re-isolation only. | |
| Secondary | Sensitivity analysis excluding ILR time after any repeat ablation. | Up to 12 months after the index procedure | |
| Secondary | Freedom from any repeat ablation procedure | Through 12 months | |
| Secondary | Composite adverse events | From the index procedure through 12 months of follow-up | |
| Secondary | The primary safety endpoint would be any adverse event related to ablation | From the index procedure through 12 months of follow-up | |
| Secondary | Differences in AF and atrial tachycardia burden between the two randomization groups (ILR) and possible predictors of this difference | From the index procedure through 12 months of follow-up | |
| Secondary | LA size, morphology, and function from echocardiographic and CT imaging data | At the index procedure | |
| Secondary | HRQoL measured with ASTA | 12 months after ablation | |
| Secondary | Correlation between arrhythmia burden and HRQoL/symptoms | At 12 months after ablation |
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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