Pacing Characteristics of a Conventional Bipolar

Condition(s) studied

Investigational drug(s) / intervention(s)

Solia S lead with any BIOTRONIK Pacemaker: * 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

Study summary

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

Eligibility

Primary outcome measure(s)

• Implant Success Rate — Baseline, 12 months
  The purpose of the primary endpoint is to evaluate the overall success rate of the implanted system, including Solia ventricular lead to sense and deliver pacing at 12- month post-implant. Successful sensing performance at 12 months is the demonstrated ability to appropriately sense without intervention for undersensing (i.e., Solia leadrelated adverse event for lead undersensing or loss of sensing) in the period from implant to 12 months, except for normal pulse generator reprogramming. Successful pacing is the demonstrated ability at 12 months to deliver a stimulation pulse with capture, without intervention (i.e., Solia lead-related adverse event for intermittent capture or no lead capture) other than normal pulse generator reprogramming. Success is determined at the subject level.

Trial sites (5)

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