Patient Enrollment: To target 120 consecutive patients while considering a 20% dropout rate, an approximate sample size of 150 patients is needed.
Treatment Plan:This is a prospective, single-arm, open-label, non-randomized, multi-center study to investigate the feasibility and stability of left bundle branch area pacing (LBBAP) for ventricular pacing in symptomatic bradycardia patients with a conventional bipolar, active fixation pacing lead. Eligible patients will be enrolled through the process of informed consent in the seven clinical investigational sites across Taiwan with competitive enrollment.
All subjects enrolled in the study will undergo LBBAP implantation using one or two Solia S leads in combination with any legally marketed BIOTRONIK pacemaker system delivered through a preshaped sheath (Selectra 3D) via left cephalic, left subclavian, or left axillary venous access. The available lengths of Solia S are 45, 53, and 60 cm. As for which one will be used, it will depend on the lead configuration and the anatomy of the subject. During the screening period, the subject's medical history and demographic information will be collected. The baseline data will be obtained prior to the pacing implantation. Depending on the needs of the subject, the screening and implantation procedures may be performed on the same day. Implant data will include lead measurements, implant technique, and lead positioning. After completion of pacemaker implantation, subjects will be followed at 1, 3, 6, and 12 months or until lead failure (dislodgment, high capture threshold, or inadequate sensing requiring revision of the lead) or death. During follow-up, a determination will be made whether the system is able to provide appropriate pacing and sensing.
Device Description:
Solia Leads: The Solia S is a family of 5.6 French, steroid-eluting, transvenous, endocardial, bipolar active fixation leads with an extendable/retractable and electrically active screw. The Solia S is manufactured, like its predecessor, the Siello S lead, in three different models (45, 53, and 60 cm in length). It has an isodiametric structure and silicone insulation. The inner and outer conductors consist of quadruple wire coils.
Solia S has a diameter of 5.6 F and is covered by a polyurethane overlay for improved gliding. It has an IS-1 connector and a 10 mm pole distance. The area between tip and ring is flexible in order to minimize the perforation risk. The fixation screw of the Solia S is electrically active and has a fractal iridium coating. The screw can be extended by 1.8 mm and has an active surface area of 4.5 mm2. The ring electrode of Solia S has a surface area of approximately 17.4 mm2 and is fractally coated with iridium. The Solia S has a dexamethasone eluting steroid collar containing 0.85 mg dexamethasone acetate. The accessories that are delivered with the lead are identical to the accessories of the Siello S.
Test Device information is below,
- Name: Solia S lead with any BIOTRONIK Pacemaker
- Model: Solia S45/S53/S60
- Manufacturer: BIOTRONIK SE & Co. KG
- Method of use: LBBAP implantation for all bradycardia indications.
- Mechanism of action: (1) Pacemaker stimulates the cardiac tissue to keep stable heart beats in patients with bradycardia. (2) LBBAP can be an alternative to right ventricular (RV) pacing to reduce RV pacing-induced ventricular dyssynchrony.
- Device category and grade: E3610 Cardiovascular devices, Class III
