Ablysinol (Dehydrated Alcohol) & Atrioventricular Block, Death, Heart Failure, Myocardial Infarction, Permanent Pacemaker Placement, Septal Myectomy, and Ventricular Arrhythmia

Basic Details
Status
Ongoing
Last Updated
Thursday, February 9, 2023
Original Posting Date
Health Outcome(s)
atrioventricular block
death
heart failure
myocardial infarction
permanent pacemaker placement
septal myectomy
ventricular arrhythmia
Purpose
Drug and Outcome Analysis
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
Yes
Analytic Code Link(s) (2)
Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: A Descriptive Analysis Cardiovascular Outcomes Following Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Procedures: An Updated Descriptive Analysis
Result(s) (1)
Frequency of Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) and Estimated Incidence Rates of Post-PTSMA Cardiovascular Outcomes: A Descriptive Analysis
Regulatory Link(s) (1)
FDA Approval Package Materials
Related Publication(s) and/or Presentation(s) (1)
Presentation: Percutaneous Transluminal Septal Myocardial Ablation and Common Procedural Complications: A Descriptive Study