Piove Di Sacco

Researchers are evaluating the use of BIOTRONIK dual-chamber pacemakers that combine left bundle branch area pacing LBBAP with Closed Loop Stimulation CLS in patients who have sinus node dysfunction SND and atrioventricular AV conduction disorders. This observational study aims to understand how this combined pacing method works in everyday clinical practice and whether it can help reduce atrial fibrillation detected by the device over 24 months. The goal is to gather real-world evidence to optimize pacemaker programming and improve patient outcomes. Participants receive permanent dual-chamber pacemakers with a ventricular lead placed in the left bundle branch area, activating the CLS rate-responsive algorithm. The study focuses on patients implanted with these devices who have no prior history of atrial fibrillation. The study follows about 150 patients for 24 months after implantation, collecting data on device-detected atrial fibrillation episodes, heart rate patterns, and pacing behavior. This is a prospective observational submodule of the BIOSTREAM.CSP registry without a control group. During the study, researchers monitor device-recorded atrial fibrillation incidence and burden from CLS activation up to 24 months. They also analyze heart rate histograms at one and two years after implantation. Patients are enrolled in the BIOSTREAM.CSP registry and are followed through routine clinical care with data collected on pacing rates and arrhythmia episodes. The study aims to provide insights into the clinical performance of CLS combined with LBBAP to inform decisions on pacemaker programming and reduce atrial arrhythmias.

This observational study evaluates the long-term outcomes, performance, and safety of BIOTRONIK devices used for conduction system pacing CSP in real-life clinical settings. It focuses on patients who receive these devices for cardiac pacing, including those with pacemakers, cardiac resynchronization therapy devices, or implantable cardioverter defibrillators, addressing conditions like bradycardia, tachycardia, and heart failure. Participants receive the Solia CSP S pacing lead for left bundle branch area pacing LBBAP as part of their routine care with BIOTRONIK devices. The study includes patients intended for new implantation or those recently implanted with investigational generators and leads positioned deep within the intraventricular septum. The study observes patients over an average of four years, monitoring device-related safety and electrical parameters through annual evaluations. Participants are involved in regular follow-up visits and use the BIOTRONIK Home Monitoring system via CardioMessenger to track device performance. Researchers measure rates of successful implantation, capture types, pacing thresholds, sensing amplitudes, and pacing impedance throughout the study. Safety is assessed by monitoring serious adverse device effects during the study period. The total participation time averages about four years, with annual assessments to support long-term device evaluation.

Researchers are evaluating the long-term clinical and instrumental response to Cardiac Contractility Modulation CCM therapy in adults with symptomatic heart failure caused by systolic left ventricular dysfunction despite adequate medical treatment. This observational cohort study, both retrospective and prospective, focuses on subjects already receiving CCM as part of their regular care. The study aims to assess clinical response, hospitalizations, quality of life, walking distance, and changes in heart biomarkers over 12 months. Participants carry the OPTIMIZER Smart Mini CCM device, a programmable implantable pulse generator connected to leads in the heart. The study groups are defined by their response to low-dose dobutamine stress echocardiography before implantation, with one group showing a reduction of 15% or more in left ventricular end-systolic volume LVESV and the other less than 15%. The low-dose dobutamine test involves incremental infusions of the drug to assess heart contractile reserve. During the 12-month follow-up, researchers will monitor changes in New York Heart Association NYHA class, hospitalizations, quality of life using the Minnesota Living with Heart Failure Questionnaire, walking test distance, and NT-proBNP biomarker levels. Additional assessments include echocardiographic measures and recording adverse events, cardiac device implants, or surgery. This comprehensive monitoring helps evaluate the clinical and functional effects of CCM therapy over time.