Trial · NCT02825979
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to recurrence of symptomatic or asymptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia | Time to first recurrence between days 91 and 365 following treatment initiation | The single procedure success (in the absence of AAD) is defined as the time to first recurrence of symptomatic\*\* or asymptomatic AF, atrial flutter, or atrial tachycardia (AF/AFL/AT) documented by 12-lead ECG, surface ECG rhythm strips, ambulatory ECG monitor, or on implantable loop recorder and lasting 120 seconds or longer as adjudicated by a blinded group of investigators between days 91 and 365 post randomization. |
| Secondary | Time to recurrence of symptomatic AF/AFL/AT | Time to first recurrence between day 0 and 365 post Ablation | Time to first recurrence of symptomatic documented AF/AFL/AT between days 91 and 365 after ablation or a repeat ablation procedure between days 0 and 365 post ablation. |
| Secondary | Total arrhythmia burden | From 91 to 365 days following treatment initiation | Total arrhythmia burden (daily AF burden - hours/day; overall AF burden - % time in AF) |
| Secondary | Total arrhythmia burden | From 91 days following treatment initiation to final follow-up (~36 months) | Total arrhythmia burden (daily AF burden - hours/day; overall AF burden - % time in AF) |
| Secondary | Major complications of ablation, or significant adverse drug events (death, ventricular pro-arrhythmia, syncope, hypotension requiring hospitalisation, pacemaker insertion). | Acute peri-procedural complications will be defined as occurring within 30 days of ablation, with delayed complications occurring 31-365 days after ablation. | Events include events death, ventricular pro-arrhythmia, syncope, hypotension requiring hospitalisation, pacemaker insertion). |
| Secondary | Economic Evaluation | to end of follow up at 36 months for each patient | Incremental cost effectiveness ratio (ICER) for ony QALY gain |
| Secondary | Health-related quality of life | Baseline, 12, 24, and 36 months following treatment initiation | Disease-specific AFEQT score, Generic EQ-5D score |
| Secondary | Symptom Status | Baseline, 12, 24, and 36 months following treatment initiation | Freedom from symptoms attributable to atrial fibrillation |
| Secondary | Healthcare utilisation | 12 and 36 months following treatment initiation | Emergency visit, cardioversion, and hospitalization \>24 hours in a healthcare facility |
| Secondary | Non-Protocol Ablation Procedure | Treatment initiation to 365 days following treatment initiation | Repeat ablation procedures in those randomized to first line catheter ablation, or any ablation procedure performed in patients randomized to AAD therapy |
| Secondary | Non-Protocol Ablation Procedure | Treatment initiation to final follow-up (~36 months) | Repeat ablation procedures in those randomized to first line catheter ablation, or any ablation procedure performed in patients randomized to AAD therapy |
| Secondary | Safety Outcomes related to Ablation or AAD therapy | Treatment initiation to final follow-up (~36 months) | Major complications of ablation, or significant adverse drug events (death, ventricular pro-arrhythmia, syncope, hypotension, pacemaker insertion). |
| Other | Time to first episode of persistent atrial tachyarrhythmia | From 91 days following treatment initiation to final follow-up (~36 months; Primary outcome of extended-follow-up study) | Time to first occurrence of symptomatic or asymptomatic persistent atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\], or atrial tachycardia \[AT\]), as defined as the first occurrence of a continuous atrial tachyarrhythmia episode lasting ≥ 7 days in duration, or lasting 48 hours to 7 days in duration but requiring cardioversion for termination, as documented by implantable loop recorder. |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02825979/registered