This study is aimed to assess the effectiveness and safety of LBBaP with Solia S and Selectra 3D in the Chinese population by analyzing the operation success rate and the system stability during follow-up visits.
All patients for whom it is the first time to receive permanent pacemaker implantation or CRT, and on whom LBBaP will be performed for trial.
Willingness to participate in the investigation and sign the ICF
Ability and willingness to perform all follow-up visits at the investigation sites
Age less than 18 years
Patients with cardiac amyloidosis
Patients with ventricular hypertrophy (interventricular septum diastolic thickness measured from two-dimensional echocardiography: ≥ 15 mm; or, interventricular septum diastolic thickness for patients with a definite family history: ≥ 13 mm)
Participating in other intervention clinical trials
Patients with an indication for permanent pacemaker implantation or CRT
Case-only
Prospective
Solia S and Selectra 3D Developed by BIOTRONIK
DeviceLBBaP with Solia S and Selectra 3D Developed by BIOTRONIK
Implantation success rate of LBBaP
Implantation success rate of LBBaP
Intraoperatively, the incidence of serious adverse events for devices associated with Solia S and Selectra 3D implantation rate
Intraoperatively, the incidence of serious adverse events for devices associated with Solia S and Selectra 3D implantation rate
Occurrence of serious adverse events rate
The incidence of serious adverse events associated with permanent pacemaker implantation or cardiac resynchronization from the time of surgery to the 12-month post-implantation visit Incidence of serious adverse events associated with the treatment procedure
Number of participants with abnormal pacing parameters and abnormal ECG readings
Assessment of the consistency of pacing parameters and ECG characteristics at 1 month and 12 months postoperatively
Changes of cardiac ultrasound values (including LVEF, LVESD and LVEDD)
At the 12-month follow-up, a cardiac ultrasound was performed, and the primary measurements included LVEF, LVESD, and LVEDD, comparing changes in LVEF, LVESD, and LVEDD at the 12-month follow-up with those prior to hospital discharge
Changes of NYHA class
The extent of change in NYHA classification and number of subjects at 1 and 12 months postoperatively.
Changes of EQ-5D-5L assessment
Extent of change in EQ-5D-5L assessment at 1 and 12 months postoperatively
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