Clinical Research Directory

PACE Cognition Proof-of-Concept Study

This proof-of-concept study will evaluate whether physiologic pacemaker programming improves cognitive function and health status in patients with symptomatic bradycardia who require permanent pacemaker implantation. Participants will be randomized to either standard pacemaker programming at 60 beats per minute or individualized physiologic rate pacing between 60 and 90 beats per minute using the myPACE algorithm. Cognitive function and health status will be assessed before pacemaker implantation and again at the routine 3-month pacemaker clinic visit. The primary outcome is change in Montreal Cognitive Assessment total score. The secondary outcome is change in SF-36 mental component summary score.

Pacing Characteristics of a Conventional Bipolar

Study Title: Pacing characteristics of a conventional bipolar, active fixation pacing lead for left bundle branch area pacing in patients with symptomatic bradycardia Study Objectives: To characterize an approach for left bundle branch area pacing (LBBAP) in patients with bradycardia indications for pacing and to assess implant success rate, safety, and long-term stability with a conventional bipolar, active fixation pacing lead. Methodology: Open-label, prospective, multi-center, non-randomized, single-arm study Study Endpoints: Primary Endpoint: • Implant success rate Secondary Endpoints: * Intra-operative procedure time and fluoroscopic exposure time * Intra-operative intracardiac electrogram (EGM) changes: paced QRS duration, stimulus to left ventricular (LV) activation time, and LBB potential * Post-operative imaging data: posteroanterior, left anterior oblique 30O, right anterior oblique 30O, Left lateral views * Serial paced 12-lead electrocardiogram (ECG) and intracardiac EGM changes: QRS duration (QRSd), pacing-QRS interval, and new atrial fibrillation (AF) * Serial echocardiography changes: left ventricular ejection fraction (LVEF), left atrial (LA) and LV chamber size, and global longitudinal strain (GLS) of tissue Doppler imaging * Serial changes of pacing parameters: capture threshold, impedance, and sensing amplitude for both atrial and ventricular Solia S leads * Safety: Immediate (\< 24 hours), in-hospital, and chronic (12 months) adverse events

Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia

This study adopts a strategy combining basic research with clinical investigation to systematically explore the therapeutic value of cardioneuroablation in the treatment of vagally-mediated bradycardia. The study design fully considers the complexity of the scientific question and the feasibility of clinical translation. Through rigorous experimental design and standardized operational procedures, the reliability and reproducibility of the study results are ensured.