Trial · NCT02825979
Early Aggressive Invasive Intervention for Atrial Fibrillation
NCT02825979, Not applicable, Unknown, Jason Andrade
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Early Aggressive Invasive Intervention for Atrial Fibrillation. Trials, record NCT02825979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02825979
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Aggressive Invasive Intervention for Atrial Fibrillation
- NCT number
- NCT02825979
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 303 participants, actual
- Lead sponsor
- Jason Andrade
- Conditions
- Atrial Fibrillation
- Interventions
- Cryoballoon-based PVI, Anti-Arrhythmic Drug Therapy
- First posted
- 2016-07-07
- Last updated
- 2022-10-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02825979
GET https://conductscience.org/api/trials/v1/NCT02825979/registered