The Heart Valve Collaboratory Mack, Michael J.; Leon, Martin B.; Wu, Changfu ...
Journal of the American College of Cardiology,
01/2022, Letnik:
79, Številka:
2
Journal Article
The FDA in the 21st Century Stockbridge, Norman, MD, PhD; Miller, Kristen, PharmD; Amur, Shashi, PhD ...
JACC. Heart failure,
2017, January 2017, 2017-01-00, Letnik:
5, Številka:
1
Journal Article
Interventional Cardiology Live Case Presentations Farb, Andrew, MD; Brown, Sheila A., RN, CCRC; Wolf, Deborah A., JD ...
Journal of the American College of Cardiology,
10/2010, Letnik:
56, Številka:
15
Journal Article
These recommendations are presented to enhance the safety and efficacy of AEDs intended for public access. The task force recommends that manufacturers present developmental and validation data on ...their own devices, emphasizing high sensitivity for shockable rhythms and high specificity for nonshockable rhythms. Alternative defibrillation waveforms may reduce energy requirements, reducing the size and weight of the device. The highest levels of safety for public access defibrillation are needed. Safe and effective use of AEDs that are widely available and easily handled by nonmedical personnel has the potential to dramatically increase survival from cardiac arrest.
The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened ...to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.
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