Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK

Recruiting now

Conditions studied: Consented to Participate in the Trial and Signed an ICF, Patients With an Indication for PM Implantation or CRTP

In brief

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.

Key facts

Study ID

NCT05793502

Run by

Chinese Academy of Medical Sciences, Fuwai Hospital

People needed

1000

Starts

2023-07-04

Expected to finish

2025-04-20

Last updated by the study team

2024-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Life-expectancy less than one year
• Pregnancy and/or breast feeding

Where it is running

• Shanxi Cardiovascular Hospital — Taiyuan, Shanxi, China (enrolling)

Full record on ClinicalTrials.gov

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