NCT05793502 Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK
| NCT ID | NCT05793502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital |
| Condition | Consented to Participate in the Trial and Signed an ICF |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-07-04 |
| Primary Completion | 2025-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-07-04 with a primary completion date of 2025-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Chen Keping, Doctor
PRINCIPAL INVESTIGATOR
Fu Wai Hospital, Chinese Academy of Medical Sciences, Fu Wai, China
Frequently Asked Questions
Who can join the NCT05793502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Consented to Participate in the Trial and Signed an ICF. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05793502 currently recruiting?
Yes, NCT05793502 is actively recruiting participants. Contact the research team at chenkepingfw@126.com for enrollment information.
Where is the NCT05793502 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT05793502 clinical trial?
NCT05793502 is sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. The principal investigator is Chen Keping, Doctor at Fu Wai Hospital, Chinese Academy of Medical Sciences, Fu Wai, China. The trial plans to enroll 1,000 participants.