CardioneuROablation for reflex syncope: efficacy and effects on autonoMic cArdiac regulatioN. The Roman 1 study
Bibliographic record
Abstract
Abstract Purpose To assess the effects of CNA on syncope recurrences in patients with VVS Methods The Roman 1 study was a prospective, randomized, investigator-initiated trial comparing CNA versus optimal standard therapy in patients with asystolic VVS. Patients were included if they had documented symptomatic cardioinhibitory or mixted spontaneous VVS (at least 3 seconds of asystole), frequent and/or severe symptoms (at least one syncope or 3 presyncopal events during preceding 12 months or very severe syncope in the past, leading to injury) and positive atropine test (>30% increase in sinus rate). CNA was performed using RF ablation of the ganlionated plexi from the left and right atrium. Follow-up lasted 2 years. Primary endpoint was time to first syncope recurrence. One of secondary endpoints were changes in quality of life (QoL) assessed using dedicated questionnaire The Impact of Syncope on Quality-of-Life Questionnaire University of Calgary. Results 48 patients (17 males, mean age 38±10, 24 – CNA group, 24 – control group) entered the study. Baseline demographic and clinical characteristics were similar in both groups. The primary end-point – syncope recurrence, occurred in 2 (8%) patients from the CNA group versus 12 (50%) controls (p=0.00037, see Kaplan-Meier curve). QoL significantly improved in the CNA group (30±10 vs 10±7 points, p=0.0001) whereas remained stable in controls (31±10 vs 30±10 points, p=0.5501). Conclusion(s) This is the first randomized study documenting efficacy of CNA in patients with asystolic VVS. Larger studies are needed to confirm these findings. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Centre of Postgraduate Medical Education
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".