Assessing the effectiveness and safety of a new pacing system for heart patients
Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK
Chinese Academy of Medical Sciences, Fuwai Hospital · NCT05793502
This study is testing a new pacing system for heart patients to see if it works better and is safer than traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital (other) |
| Locations | 1 site (Taiyuan, Shanxi) |
| Trial ID | NCT05793502 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness and safety of the LBBaP technique using Solia S and Selectra 3D devices in patients requiring permanent pacemaker implantation or cardiac resynchronization therapy (CRT) in China. The study aims to analyze the operation success rate and system stability during follow-up visits, addressing the limitations of traditional right ventricular pacing. By utilizing His bundle pacing, the study seeks to improve patient outcomes and reduce risks associated with conventional pacing methods.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing their first permanent pacemaker implantation or CRT who are willing to participate in follow-up visits.
Not a fit: Patients under 18 years, those with cardiac amyloidosis, ventricular hypertrophy, or those participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and reduced hospitalization rates for patients with bradycardia arrhythmia.
How similar studies have performed: Previous studies have shown promising results for His bundle pacing, indicating potential benefits over traditional pacing methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taiyuan, Shanxi
- Shanxi Cardiovascular Hospital — Taiyuan, Shanxi, China (RECRUITING)
Study contacts
- Principal investigator: Chen Keping, Doctor — Fu Wai Hospital, Chinese Academy of Medical Sciences, Fu Wai, China
- Study coordinator: Chen Keping, Doctor
- Email: chenkepingfw@126.com
- Phone: 13811266140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Consented to Participate in the Trial and Signed an ICF, Patients With an Indication for PM Implantation or CRTP