Precision Lead Delivery for Advanced Conduction System Pacing

Summary The cardiac conduction system (CCS) is a new target for pacing that is rapidly replacing traditional heart stimulation due to its overwhelming advantages. Precise CCS lead delivery is limited by the absence of specialized tools. We propose a novel lead delivery platform to precisely identify and safely deliver CCS pacing leads. We will develop a 3D pre-shaped delivery catheter with a novel feature to enable physicians to monitor pacing parameters, implant depth and CCS capture with minimal damage to heart tissues. Traditional right ventricular (RV) apical pacing is a well-established technology with more than 1MM implants annually but with a possibility of left ventricular dysfunction and heart failure. CCS pacing (CSP) is devoid of these complications. The latest technique for CSP, Left Bundle Branch (LBB) Area Pacing (LBBAP), is improved over the earlier direct His bundle pacing (easier target and stable pacing parameters). The pacing lead is delivered through a pre-shaped catheter and advanced deep into the interventricular septum in the vicinity of LBB. LBBAP is still limited by poor localization of the exact target, potential need for multiple probing attempts with the entire lead, and absence of specialized tools to minimize the effort and damage to the septum. The core novelty of our approach is in the idea of using a delivery system that will allow the physician to sequentially map the septal myocardium, fix the delivery catheter at the optimal location, followed by lead delivery at the optimal site. We have fabricated initial functional prototypes and used these in representative models. Initial bench and ex-vivo testing supports improved lead delivery mechanics and precision. Reduced tissue trauma with the novel delivery system was also initially appreciated. This preliminary work and prior experience position us well to further develop this novel concept. As part of this Phase I program we will accomplish the following specific aims: Specific Aim 1 - Develop fully functional catheters and stylet prototypes. • Task 1.1 Design 3-5 iterations of the 3D pre-shaped lead delivery catheter with a second braid-embedded stylet lumen and extendable electrically insulated pacing and mapping stylet with radio-opaque markers. • Task 1.2 Perform mechanical and electrical characterization of the catheter and stylet (torque, stiffness, interoperability, impedance, etc.). Specific Aim 2 - Demonstrate stability and precision of delivery system in a bench model with experienced clinicians. • Task 2.1 Fabricate representative right heart models based on CT data. • Task 2.2 Perform simulated lead delivery using stylet-based and conventional methods. Compare procedural characteristics between the standard and prototype delivery systems and stylets based on the 9-partition septum model. Deliverability appropriate segments and quantitative operator feedback to be assessed and compared between systems. Specific Aim 3 - Assess overall system performance and tissue damage to the septum from stylet vs. lead helix. • Task 3.1 Perform simulated lead delivery in an ex vivo electrically active sheep heart model compared to conventional delivery systems/leads including procedural characteristics, pacing parameters and assessment of tissue damage with both methods. • Task 3.2 Evaluate different stylet prototypes and compare recording/pacing characteristics with standard leads. • Task 3.3 Develop initial US regulatory strategy including potential FDA pre-submission meeting. The goal of this project is to address key shortcomings in LBBAP using a novel delivery catheter. This will enable more precise, faster and safer lead delivery in a rapidly expanding population of patients.