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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Solia S and Selectra 3D Developed by BIOTRONIK

Treatment groups

1,000 Participants
are divided into 1 treatment group