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Pacing Characteristics of a Conventional Bipolar

NCT06011252 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-05-13

No results posted yet for this 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

Conditions

  • Symptomatic Bradycardia

Interventions

DEVICE

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

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    collaborator INDUSTRY

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chun Chieh Wang · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-03-31
Completion
2026-06-16

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011252 on ClinicalTrials.gov