Subject(s)
Maternal Health , Prenatal Exposure Delayed Effects , Female , Humans , Particulate MatterABSTRACT
The WiSE system is a novel, leadless endocardial system that can provide cardiac resynchronization therapy in patients who cannot be treated with a conventional epicardial left ventricular lead. Safety and efficacy were being evaluated in the pivotal, randomized, double-blind SOLVE-CRT Trial (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy.) The trial was initiated in 2018; however, patient enrollment was significantly impacted by the COVID-19 pandemic necessitating a change in design. This article describes the revised trial and the scientific rationale for the specific changes in the protocol.
Subject(s)
COVID-19/epidemiology , Cardiac Resynchronization Therapy/methods , Endocardium , Heart Failure/therapy , Pandemics , Cardiac Resynchronization Therapy/adverse effects , Double-Blind Method , Humans , Prospective Studies , Sample Size , Time Factors , Treatment Outcome , Ventricular Function, LeftABSTRACT
Shared decision making with patients in advanced heart failure is critical when making decisions on therapies such as left ventricular assist device implantation and cardiac transplantation. We describe a case wherein the risks of coronavirus disease-2019 affected the decision of a patient regarding proceeding with cardiac transplantation. (Level of Difficulty: Beginner.).