Biotronik said yesterday that it launched a study of its new implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems.
The BIO|MASTER.Cor Family study will explore clinical safety and workflow benefits of its ICD and CRT-D systems, specifically focused on gains from the thinner and more rounded shape, the Berlin-based company said.
Biotrink said that the first patient in the trial has been enrolled and received a Rivacor 5 HF-T QP device at Riga, Latvia’s Pauls Stradins Clinical University Hospital.
“My first implementation of a Rivacor CRT-D as part of the BIO|MASTER.Cor Family Study was very successful. The thinner device with its elliptical BIOshape helped improve handling and implementation,” Dr. Andrejs Erglis said in a prepared statement.
The trial aims to enroll a total of 127 patients with standard indications for ICD and CRT-D therapy and will explore the use of the Acticor 7, Rivacor 7 and 5 and the Plexa ProMRI S DX lead, the company said.
Endpoints in the trial include the serious adverse device effect-free rate for the Cor family ICDs, the automatic LV VectorOpt test for the automatic measurement of LV pacing thresholds and the CRT AutoAdapt feature. Follow-ups in the trial are planned at pre-hospital discharge, three and six months and one year post-implant.
“The goal of the BIO|MASTER.Cor Family Study is to provide supporting evidence for the performance of the new Acticor and Rivacor ICD and CRT-D devices and the Plexa ProMRI S DX lead—particularly what this new technology can do to streamline work in clinics like ours. With the results of this prospective study, we hope to improve clinical therapy and research,” coordinating investigator Dr. Jan Steffel of Switzerland’s University Hospital Zurich said in a prepared release.
“With our new innovative ICD/CRT-D platform Acticor & Rivacor and our dedication to clinical research, we are confident that the BIO|MASTER.Cor Family Study will contribute to improved therapy methods. Biotronik currently runs 31 clinical studies worldwide in the CRM/EP area and is strongly committed to providing physicians with profound clinical data for optimal patient therapy,” Biotronik corporate marketing senior VP Dr. Alexander Uhl said in a press release.
Earlier this month, Biotronik said that it launched enrollment in what it claims to be the first large-scale prospective study exploring sex-specific outcomes in patients with non-ischemic cardiomyopathy treated with a cardiac defibrillator.