Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. Mostly, ventricular tachycardia and ventricular fibrillation are the underlying aetiology of SCA, which is claimed to be successfully treated by a novel defibrillation therapy, a wearable cardioverter defibrillator (WCD).
The assessment aimed to provide valid data on clinical effectiveness and safety of the WCD. Comparators were chosen based on CE mark indications, recommendations from relevant published clinical guidelines and according to the EUnetHTA guidelines. Furthermore, the project intended to elicit patients’ views on aspects regarding their cardiac disease and the WCD therapy as well as to identify neglected outcomes.
Final version of the assessment was published in December 2016
Below is the documentation provided by the Joint Assessment authoring team:
Comments+Answers_2nd_draft_Assessment
FINAL_Project_Plan_EUnetHTA_WCD_LifeVest_18082016_without_appendix
