Biotronik launches 2 new studies

Biotronik announced 2 new studies last week that are slated to examine the company’s CRT-D device and BioMonitor implanted cardiac monitor. A 277-patient BioContinue clinical trial will examine the risk of ventricular arrhythmias after CRT-D replacement, enrolling patients over 2 years at 40 centers across 8 countries, the company said. Biotronik said the trial will be the 1st to investigate defibrillator back-up following device placement in heart failure patients with a primary indication for cardiac resynchronization therapy defibrillators. Patients in the trial will be implanted with Biotronik’s CRT-Ds and assessed for the rate of ventricular tachyarrhythmias over 2 years. Biotronik said that it looks to evaluate the risk of VTA or ventricular fibrillation after replacement, with a primary endpoint being the number of patients with at least one sustained VTA or VF. “Eighty percent of ICD patients implanted for primary prevention do not experience a VTA during the lifetime of their first device. In addition, if these HF patients successfully respond to CRT during their initial device’s lifetime, they may no longer be indicated for defibrillator back-up by the time it is due for replacement. However, even if a patient no longer fulfills the criteria for a defibrillator at the time of CRT-D replacement, the risk of subsequent ventricular arrhythmia could remain. Our goal is to create a risk mapping profile according to individual patient characteristi...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Research & Development Biotronik Source Type: news