LAKE OSWEGO, Ore., United States, December 13, 2022 – BIOTRONIK, a global leader in the treatment of cardiac and vascular disease is pleased to announce the first patient enrollment in BIO-CONDUCT, an FDA approved investigational device exemption (IDE) trial examining the use of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area, a location for which the Solia S lead is not currently approved. Left bundle branch area pacing, a form of conduction system pacing, is an emerging technique for providing a more physiologic activation of cardiac tissue in patients needing ventricular pacing support. This pacing site may also help avoid the detrimental effects of traditional right ventricular pacing.1, 2
The first patient enrollment and implant occurred at the NYU Langone Heart Rhythm Center and was performed by Dr. Larry Chinitz, Co-Director of NYU Langone Heart, Director of Cardiac Electrophysiology and the NYU Langone Heart Rhythm Center, as well as a lead investigator in the trial. “Conduction system pacing, and left bundle branch area pacing in particular, represents a crucial area of current research,” says Dr. Chinitz. “This study represents the first time a stylet-driven lead, the Solia S, has been studied specifically in the setting of conduction system pacing. Understanding the acute and long-term performance of these leads within this clinical application is a critical step in advancing this new treatment option for patients. Given the encouraging results of previous trials with physiologic pacing, the ability to achieve these endpoints with stylet driven leads will likely increase patient access and possibly augment the favorable outcomes.”
The IDE trial will seek to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when used in the left bundle branch area. The trial is expected to enroll up to 260 patients for evaluation at up to 25 sites in the United States. The trial will be conducted over 12 months and will include evaluation of safety and effectiveness as well as patient quality of life measurements.
Compared to traditional right ventricular pacing, conduction system pacing such as LBB area pacing has been proposed as a more physiologic alternative. “There is a great deal of excitement surrounding conduction system pacing, and we are eager to provide additional clinical data to physicians who want to use our leads for this emerging pacing option,” says Dr. David Hayes, Chief Medical Officer of BIOTRONIK. “BIOTRONIK is committed to advancing cardiac care, and we will continue to support efforts that enable physicians to treat their patients most effectively.”
Caution: Investigational device, limited by US law to investigational use.
References:
1. Zhang S, Guo J, Tao A, et al. Clinical outcomes of left bundle branch pacing compared to right ventricular apical pacing in patients with atrioventricular block. ClinCardiol. 2021 Apr;44(4):481-487. doi: 10.1002/clc.23513.
2. Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7.
