Study of Left Bundle Branch Area Pacing Using Tendril STS 2088TC or UltiPace LPA1231 Leads for Heart Conditions

What this Trial Is About

Researchers are studying the safety and effectiveness of left bundle branch area LBBA pacing and sensing in patients who have been implanted with either the Tendril STS 2088TC or UltiPace LPA1231 pacing leads. This trial is a global, prospective, single-arm, multi-center study designed to support expanding the approved use of these leads to include pacing and sensing specifically in the LBBA. The study focuses on patients with various cardiac conditions such as bradycardia, heart failure, atrial fibrillation, and conduction system pacing. The study involves implanting the Tendril STS 2088TC or UltiPace LPA1231 leads in the LBBA for pacing and sensing. These are bipolar, steroid-eluting, active fixation, MR Conditional leads that can also be placed in other heart chambers but are being evaluated here specifically for the LBBA location. The leads are used with compatible pacemakers, implantable cardioverter defibrillators, or cardiac resynchronization therapy devices. Data will be collected from the time of implant through six months post-implant. Participants will have scheduled follow-up visits during the six months after implantation to monitor device performance and patient safety. Researchers will assess outcomes such as infection rate, lead malfunction, cardiovascular injury, implant success, lead dislodgement, pacing threshold, impedance, and sensing amplitude. Participants must comply with study procedures and return for all required visits, tests, and exams. The study duration for each participant is six months after implant.

Left Bundle Branch Area Pacing (LBBAP) PMCF Study