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  "documentTitle": "AtriCure, Inc. (ATRC)",
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  "presentationDate": "2020-09-01 00:00:00",
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  "notes": "Critique of AtriCure's CONVERGE trial, specifically challenging the control group comparability.",
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      "text": "The major flaw in the trial design is that the catheter ablation control group just isn’t comparable to the Convergent group.",
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      "text": "But a detailed examination of the trial design and the results suggests that Convergent will end up at the same impasse as AtriCure's prior minimally invasive endeavors – an overly complicated procedure offering few incremental benefits for the incremental cost.",
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      "text": "The Hybrid Convergent Arm (102 patients); The Endocardial Catheter Ablation arm (51 patients).",
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      "text": "In the Convergent arm, 67.7% of patients were free from AF/AFL/AT at 12 months, while in the Endocardial Catheter Ablation arm, that proportion was only 50%. Through 30 days post-procedure, the Hybrid Convergent arm had 7.8% severe adverse events.",
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      "text": "At the time of the acquisition, nContact had already initiated a randomized controlled trial – CONVERGE – which sought to compare the efficacy of the Convergent hybrid procedure to that of PVI by catheter ablation.",
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      "text": "Having seemingly demonstrated an “acceptable safety profile and superior effectiveness... AtriCure’s contention is that CONVERGE is definitive proof... But a detailed examination... suggests that Convergent will end up at the same impasse.",
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      "text": "The primary effectiveness endpoint was freedom from AF, atrial tachycardia (AT), and atrial flutter (AFL) as measured by a 24-hour Holter monitor 12 months after the procedure.",
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      "text": "In the Convergent arm, 67.7% of patients were free from AF/AFL/AT at 12 months, while in the Endocardial Catheter Ablation arm, that proportion was only 50%.",
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      "text": "A detailed discussion of the DEEP procedure is undertaken by Jared Beller and colleagues in Beller, J, et al, Minimally Invasive Atrial Fibrillation Surgery: Hybrid Approach",
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