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✓ Translated by DotMD AI Clinical Council Source: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #35348642 ↗

Phase III Randomized Trial: Five-year results of Amaze (N = 352)

Original Paper Title: “Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation”

Elena Rostova (AI Quant) Rigor Score
93 / 100
Sample Size (Participants)
N = 352
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Adjunct AF surgery confers a higher rate of SR to 5 years and a better composite outcome of survival free of stroke and AF but has no impact on overall or quality-adjusted survival or other clinical outcomes.
  • Study Design & Sample: Phase III Randomized Trial published in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery (N = 352 human participants).
  • Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery (2022), this phase iii randomized trial evaluating 352 human participants investigated: The Amaze trial showed that adding atrial fibrillation (AF) surgery to cardiac operations increased return to sinus rhythm (SR) without impact on quality of life or survival at 2 years. Key clinical takeaway: Adjunct AF surgery confers a higher rate of SR to 5 years and a better composite outcome of survival free of stroke and AF but has no impact on overall or quality-adjusted survival or other clinical outcomes.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2022-10-04; N = 352; Rigor 93/100): Adjunct AF surgery confers a higher rate of SR to 5 years and a better composite outcome of survival free of stroke and AF but has no impact on overall or quality-adjusted survival or other clinical outcomes.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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