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Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: A Descriptive Analysis

    Basic Details
    Date Posted
    Thursday, February 9, 2023
    In progress
    Medical Product
    dehydrated alcohol
    Health Outcome(s)
    atrioventricular block
    heart failure
    permanent pacemaker placement
    septal myectomy
    ventricular arrhythmia

    The goals of this analysis were to identify and count percutaneous transluminal septal myocardial ablation (PTSMA) procedures and to estimate incidence rates of post-PTSMA cardiovascular outcomes in the Sentinel Distributed Database (SDD). We distributed this request to six Sentinel Data Partners on August 5, 2022. The study period includes data from January 1, 2014 to December 31, 2021. 

    The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    Time Period
    January 1, 2014 – December 31, 2021
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)