A randomized controlled trial of pulsed field ablation vs antiarrhythmic therapy as a first-line treatment for persistent atrial fibrillation: The AVANT GUARD trial rationale and design
Bibliographic record
Abstract
Background: Recent studies have established catheter ablation as a safe and superior alternative to antiarrhythmic drugs (AADs) as a first-line therapy in patients with paroxysmal atrial fibrillation (AF). There are no randomized controlled trials assessing this strategy in patients with persistent AF. Objective: This study aims to establish the safety and effectiveness of pulsed field ablation (PFA) as a first-line treatment for persistent AF compared with AAD therapy. Methods: AVANT GUARD (A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation vs Anti-Arrhythmic Drug Therapy as a First Line Treatment for Persistent Atrial Fibrillation) is a multicenter, global, pivotal investigational device exemption study that compares the safety and effectiveness of PFA with the pentaspline PFA catheter to AADs as first-line therapy for patients with persistent AF. All patients will receive an implantable cardiac monitor. Results: The primary safety end point, evaluated in PFA subjects, is a composite of defined acute and chronic device- and procedure-related serious adverse events. The primary effectiveness end point, evaluated in randomized PFA and AAD subjects at 12-month follow-up, is a composite of acute and chronic treatment success including freedom from atrial arrhythmia recurrence lasting ≥30 seconds (symptomatic) or ≥1 hour (asymptomatic), electrical cardioversion, or (re)ablation. Conclusion: AVANT GUARD will help fill a critical gap in our understanding of treatment approaches and disease progression for patients with persistent AF by providing a direct comparison between ablation using PFA versus AAD treatment as a first-line therapy with continuous monitoring to assess outcomes.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.009 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".