Prospective Randomized Trial of Rotor Ablation vs Conventional Ablation for Persistent Atrial Fibrillation: REAFFIRM Trial
Bibliographic record
Abstract
Background Pulmonary vein isolation (PVI) is the cornerstone therapy for symptomatic drug‐refractory atrial fibrillation yet is not curative in a large segment of patients. Focal and rotational drivers are proposed to be involved in atrial fibrillation mechanisms but their ablation has produced variable outcomes. REAFFIRM (The Randomized Evaluation of Atrial Fibrillation Treatment with Focal Impulse and Rotor Modulation Guided Procedures) trial (NCT‐02274857) objective was to compare the safety and effectiveness of conventional ablation with and without Focal Impulse and Rotor Modulated (FIRM) ablation, guided by global basket mapping, for the treatment of persistent atrial fibrillation. Methods Three hundred seventy‐five patients were enrolled and randomized at 18 centers. The Intent‐to‐Treat population consisted of 350 patients (171 FIRM, 179 Conventional). Primary effectiveness was defined as single procedure freedom from atrial fibrillation/atrial tachycardia recurrence at 3 to 12 months post index procedure. Results Three hundred twenty‐four patients completed the 12‐month follow‐up. Patients in the FIRM arm had a larger left atrium ( P <0.01). Primary effectiveness at 3 to 12 months was 69.3% in FIRM and 67.5% in Conventional (NS), with no difference in ablation procedure time or safety. A subset of patients (41% FIRM, 49% Conventional) received extra ablation. Primary effectiveness in the on‐treatment subgroups was 65% PVI‐only, 69.6% PVI +extra, 77.7% FIRM+ PVI‐only, and 57.7% FIRM+ PVI +extra ( P =0.09). Conclusions Intention‐to‐treat analysis failed to provide evidence for the superiority of adding ablation of focal or rotational sites to conventional ablation. Registration URL: https://clinicaltrials.gov ; Unique Identifier: NCT‐02274857.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.010 | 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".