Trial · NCT04704050
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-ablation Atrial Fibrillation Recurrence | Up to 56 weeks. From date of ablation until the date of first documented Atrial Fibrillation recurrence, whichever came first, assessed up to 56 weeks. | Investigators monitored subjects upon discharge, 24-48 hours after AF ablation. This was recorded by either the occurrence of a single positive atrial arrhythmias (AA) ECG reading on a 12-lead ECG, Holter monitor, obtained on the daily event strips from the Preventice monitoring device, or 30-day monitoring patch. |
| Primary | Post-ablation Atrial Fibrillation Recurrence Documented by an AAD Initiation | Up to 56 weeks. From date of ablation until the date of first documented Atrial Fibrillation recurrence, whichever came first, assessed up to 56 weeks. | New anti-arrhythmic drug (AAD) initiation for AF recurrence after AF ablation, including initiation of the treatment during the blanking period, or with no available positive ECG reading. |
| Secondary | Atrial Fibrillation Episodes | At baseline, at month 3, at month 12 | Atrial arrhythmia (AA) episodes associated with palpitations, chest pain, dyspnea, dizziness, syncope, or unusual fatigue and weakness were assessed using the Atrial Fibrillation Severity Scale (AFSS) questionnaire. The AFSS is a validated questionnaire designed to measure the burden of atrial arrhythmias, including atrial fibrillation and other irregular heart rhythms. The AA symptom burden score is derived from the AFSS summary score, which averages the frequency, duration, and patient-perceived severity of AA episodes. The AFSS symptom burden score ranges from 3 to 30, with higher scores indicating greater AA burden. Subscale scores (frequency, duration, and severity) are each rated on a scale of 1 to 10 and are averaged to calculate the total burden score. Patients completed the AFSS at baseline, 3 months, and 12 months. Reported data in the results table reflect the mean score at the 12-month time point. |
| Secondary | Repeat Cardiac Ablation | 1 year | Whether patients in either treatment arm require a repeat cardiac ablation. |
| Secondary | Cardioversion | 1 year | Whether patients in either treatment arm require cardioversion. |
| Secondary | Atrial Fibrillation Burden | 1 year | The percentage of time a patient is in atrial fibrillation during the monitoring period, 24-48 hours and, at 3 months and 12 months post-ablation. Burden will be recorded as a time-weighted average (%) based on data from wearable devices. |
| Secondary | Quality of Life (Online Questionnaire Form) | At baseline, at month 3, at month 12 | Quality of life (QoL) was assessed through the Atrial Fibrillation Severity Scale (AFSS), a validated instrument that evaluates the impact of AF across multiple domains, including symptom burden, health care utilization, and overall well-being. The Global Well-being domain of the AFSS is assessed using a single-item question (A4), which measures overall quality of life on a scale from 1 to 10, where higher scores indicate better quality of life. Patients completed the questionnaire at baseline, 3 months, and 12 months. The reported data in the results table reflect the mean score at the 12-month time point. |
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Through trial completion, up to 56 weeks. | Assessment of adverse events related to treatment given. Evaluated at 3, 12 months visits and during 6 \& 9 month phone call visits. |
| Other | Hospitalization | 1 year | Records of any cardiac events requiring hospitalization. |
| Other | Mortality | 1 year | Records of mortality associated with cardiovascular events. |
| Other | Stroke/ Transient Ischemic Attacks (TIA) | 1 year | Records of stroke or TIA based on cardiac emboli. |
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.
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