RecruitingNCT05793502
Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Enrollment
1,000 participants
Start Date
Jul 4, 2023
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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
Exclusion Criteria6
- 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
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Interventions
DEVICESolia S and Selectra 3D Developed by BIOTRONIK
LBBaP with Solia S and Selectra 3D Developed by BIOTRONIK
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05793502