Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion criteria 1. 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. 2. Willingness to participate in the investigation and sign the ICF 3. Ability and willingness to perform all follow-up visits at the investigation sites Exclusion criteria 1. Age less than 18 years 2. Patients with cardiac amyloidosis 3. 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) 4. Participating in other intervention clinical trials 5. Life-expectancy less than one year 6. Pregnancy and/or breast feeding