LBBaP Procedure with Solia S and Selectra 3D Pacemakers
Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK
Recruiting
Observational Study
Consented to Participate in the Trial and Signed an ICFPatients With an Indication for PM Implantation or CRTP
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital · Other
Who this trial is looking for
This trial is looking for patients who need a permanent pacemaker or CRT. Participants will have the LBBaP procedure and return for follow-up visits to see how well it's working.
Are You a Good Fit for This Trial?
You may be able to join if
I am receiving my first permanent pacemaker implantation or CRT.
I am willing to participate in the trial and sign the consent form.
I can attend all follow-up visits at the trial sites.
You may not be able to join if
I am under 18 years old.
I have cardiac amyloidosis.
I have ventricular hypertrophy.
I am participating in another clinical trial.
I have a life expectancy of less than one year.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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City
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Status
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 i…
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
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