Consented to Participate in the Trial and Signed an ICFNCT05793502
Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK
An observational study of Consented to Participate in the Trial and Signed an ICF and Patients With an Indication for PM Implantation or CRTP, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consented to Participate in the Trial and Signed an ICF, Patients With an Indication for PM Implantation or CRTP
- What is being tested?
- Solia S and Selectra 3D Developed by BIOTRONIK
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2023to 20 Apr 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication for permanent pacemaker implantation or CRT
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi
XIAOMING LI
About this study
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.
Read the detailed description
Traditional ventricular pacing leads are placed in and around the right ventricular apex (RVA), which are easy to operate. The long-term safety and efficacy of right ventricular pacing (RVP) in the treatment of bradycardia arrhythmia have been demonstrated. However, it is shown by CTOPP (Canadian Trial of Physiologic Pacing) study (1), MOST (Micro-Optical Sectioning Tomography) study (2) and UKPACE (United Kingdom Pacing and Cardiovascular Events) study (3) that long-term and high-proportion right ventricular apical pacing (RVAP) may lead to ventricular systolic asynchrony, and accordingly increase the risks of cardiac failure (cardiac insufficiency) and atrial fibrillation (AF).
The concept of His bundle pacing (HBP) has been put forward for a long time, in which His bundle is directly stimulated to synchronously excite the ventricles mainly through the conduction of the His-Purkinje system (HPS) in the electrical activity of the heart. The study performed by Vijayaman et al. (4) shows that HBP can reduce the long-term mortality and the risks of hospitalization for cardiac failure and upgrading to CRT compared with the traditional RVAP. However, HBP surgery has the following disadvantages: (1) It is rather difficult to fix the leads, the operation duration is long, the suture removal duration is long, and the learning curve of doctors is long; (2) The threshold value is high during implantation and may further increase in the long term, and the sensory power is rather low. Therefore, the implantation of spare leads is recommended in relevant guidelines, increasing the hardware burden in patients; (3) The implantation site of patients with conduction block below His bundle is rather difficult or unable to cross the block site.
In order to improve the HBP surgery, Chinese doctors have put forward LBBaP in recent years, arousing widespread concern all over the world. Dedicated sheath tubes and electrode leads are adopted in the technique. Specifically, electrode leads are "screwed" into the left bundle branch area under the left ventricular intima from the right ventricular septum (RVS), and the left bundle branch pacing (LBBP) is performed to improve bradycardia. Compared with HBP, LBBP has the following advantages: (1) As the implantation site is easier to locate, the operation difficulty is reduced; (2) With a lower and more stable threshold, the sensitivity is better; (3) Distal block is corrected; (4) An enough space is left for atrioventricular junction ablation.
At present, it is collectively known as HBP in the international community. LBBaP refers to conduction system pacing, the performing of which depends on dedicated tools or instruments. In early times, the positioning and fixation of shaping steel wires in combination with active-fixation leads adopted in the technique were realized with the aid of a mapping catheter. The operation success rate of HBP was rather low and LBBaP could not be realized. With the introduction of dedicated sheath tubes by various manufacturers, the operation success rate has been greatly improved. However, there are no enough data derived from large-scale studies at home and abroad on the effectiveness and safety of LBBaP with Selectra 3D and Solia S developed by BIOTRONIK at present.
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.
- Conditions
- Consented to Participate in the Trial and Signed an ICF, Patients With an Indication for PM Implantation or CRTP
- Being tested
- Solia S and Selectra 3D Developed by BIOTRONIK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solia S and Selectra 3D Developed by BIOTRONIKDevice
LBBaP with Solia S and Selectra 3D Developed by BIOTRONIK
| Study group | Role | What they receive |
|---|---|---|
| Permanent pacemaker implantation or cardiac resynchronization therapy | Patients with an indication for permanent pacemaker implantation or CRT Receives: Device: Solia S and Selectra 3D Developed by BIOTRONIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation success rate of LBBaP
Implantation success rate of LBBaP
Measured: During the surgery
Intraoperatively, the incidence of serious adverse events for devices associated with Solia S and Selectra 3D implantation rate
Intraoperatively, the incidence of serious adverse events for devices associated with Solia S and Selectra 3D implantation rate
Measured: During the surgery
Occurrence of serious adverse events rate
The incidence of serious adverse events associated with permanent pacemaker implantation or cardiac resynchronization from the time of surgery to the 12-month post-implantation visit Incidence of serious adverse events associated with the treatment procedure
Measured: From the time of surgery to the 12-month post-implantation visit
Secondary outcomes (4)
Number of participants with abnormal pacing parameters and abnormal ECG readings
Assessment of the consistency of pacing parameters and ECG characteristics at 1 month and 12 months postoperatively
Measured: 1 month and 12 months post-procedure
Changes of cardiac ultrasound values (including LVEF, LVESD and LVEDD)
At the 12-month follow-up, a cardiac ultrasound was performed, and the primary measurements included LVEF, LVESD, and LVEDD, comparing changes in LVEF, LVESD, and LVEDD at the 12-month follow-up with those prior to hospital discharge
Measured: 12 months post-procedure.
Changes of NYHA class
The extent of change in NYHA classification and number of subjects at 1 and 12 months postoperatively.
Measured: 1 month and 12 months post-procedure
Changes of EQ-5D-5L assessment
Extent of change in EQ-5D-5L assessment at 1 and 12 months postoperatively
Measured: 1 month and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start4 Jul 2023
- Primary completion20 Apr 2025 (estimated)
- Study completion20 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consented to Participate in the Trial and Signed an ICFStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Keping, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Chen Keping, Doctor, Principal investigator, Fu Wai Hospital, Chinese Academy of Medical Sciences, Fu Wai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793502
- Sponsor's protocol ID
- 20230320
- Status last verified
- Aug 2024
- First submitted
- 20 Mar 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The project is a prospective, multicenter and single-group observational study. A total of 1,000 subjects will be enrolled at 20 investigation sites within the territory of China. All subjects enrolled will receive permanent pacemaker implantation or cardiac resynchronization therapy (CRT), and LBBaP will also be performed on them for trial. They will be followed up at pre-hospital discharge, and 1 month and 12 months post-procedure. Data collected in the investigation will be analyzed to assess the effectiveness and safety of LBBaP with Solia S and Selectra 3D in the Chinese population.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Effectiveness and Safety of LBBaP With Solia S and Selectra 3D Developed by BIOTRONIK
- ClinicalTrials.gov ID
- NCT05793502
- Acronym / sponsor ID
- 20230320
- Conditions
- Consented to Participate in the Trial and Signed an ICF, Patients With an Indication for PM Implantation or CRTP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Traditional ventricular pacing leads are placed in and around the right ventricular apex (RVA), which are easy to operate. The long-term safety and efficacy of right ventricular pacing (RVP) in the treatment of bradycardia arrhythmia have been demonstrated. However, it is shown by CTOPP (Canadian Trial of Physiologic Pacing) study (1), MOST (Micro-Optical Sectioning Tomography) study (2) and UKPACE (United Kingdom Pacing and Cardiovascular Events) study (3) that long-term and high-proportion right ventricular apical pacing (RVAP) may lead to ventricular systolic asynchrony, and accordingly increase the risks of cardiac failure (cardiac insufficiency) and atrial fibrillation (AF).
The concept of His bundle pacing (HBP) has been put forward for a long time, in which His bundle is directly stimulated to synchronously excite the ventricles mainly through the conduction of the His-Purkinje system (HPS) in the electrical activity of the heart. The study performed by Vijayaman et al. (4) shows that HBP can reduce the long-term mortality and the risks of hospitalization for cardiac failure and upgrading to CRT compared with the traditional RVAP. However, HBP surgery has the following disadvantages: (1) It is rather difficult to fix the leads, the operation duration is long, the suture removal duration is long, and the learning curve of doctors is long; (2) The threshold value is high during implantation and may further increase in the long term, and the sensory power is rather low. Therefore, the implantation of spare leads is recommended in relevant guidelines, increasing the hardware burden in patients; (3) The implantation site of patients with conduction block below His bundle is rather difficult or unable to cross the block site.
In order to improve the HBP surgery, Chinese doctors have put forward LBBaP in recent years, arousing widespread concern all over the world. Dedicated sheath tubes and electrode leads are adopted in the technique. Specifically, electrode leads are "screwed" into the left bundle branch area under the left ventricular intima from the right ventricular septum (RVS), and the left bundle branch pacing (LBBP) is performed to improve bradycardia. Compared with HBP, LBBP has the following advantages: (1) As the implantation site is easier to locate, the operation difficulty is reduced; (2) With a lower and more stable threshold, the sensitivity is better; (3) Distal block is corrected; (4) An enough space is left for atrioventricular junction ablation.
At present, it is collectively known as HBP in the international community. LBBaP refers to conduction system pacing, the performing of which depends on dedicated tools or instruments. In early times, the positioning and fixation of shaping steel wires in combination with active-fixation leads adopted in the technique were realized with the aid of a mapping catheter. The operation success rate of HBP was rather low and LBBaP could not be realized. With the introduction of dedicated sheath tubes by various manufacturers, the operation success rate has been greatly improved. However, there are no enough data derived from large-scale studies at home and abroad on the effectiveness and safety of LBBaP with Selectra 3D and Solia S developed by BIOTRONIK at present.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Permanent pacemaker implantation or cardiac resynchronization therapy | – | Device: Solia S and Selectra 3D Developed by BIOTRONIKPatients with an indication for permanent pacemaker implantation or CRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for permanent pacemaker implantation or CRT
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solia S and Selectra 3D Developed by BIOTRONIKLBBaP with Solia S and Selectra 3D Developed by BIOTRONIK | Device | Permanent pacemaker implantation or cardiac resynchronization therapy |
Primary outcome
Implantation success rate of LBBaP
Time frame: During the surgery
Implantation success rate of LBBaP
Intraoperatively, the incidence of serious adverse events for devices associated with Solia S and Selectra 3D implantation rate
Time frame: During the surgery
Intraoperatively, the incidence of serious adverse events for devices associated with Solia S and Selectra 3D implantation rate
Occurrence of serious adverse events rate
Time frame: From the time of surgery to the 12-month post-implantation visit
The incidence of serious adverse events associated with permanent pacemaker implantation or cardiac resynchronization from the time of surgery to the 12-month post-implantation visit Incidence of serious adverse events associated with the treatment procedure
4 secondary outcomes
Number of participants with abnormal pacing parameters and abnormal ECG readings
Time frame: 1 month and 12 months post-procedure
Changes of cardiac ultrasound values (including LVEF, LVESD and LVEDD)
Time frame: 12 months post-procedure.
Changes of NYHA class
Time frame: 1 month and 12 months post-procedure
Changes of EQ-5D-5L assessment
Time frame: 1 month and 12 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No. The project is a prospective, multicenter and single-group observational study. A total of 1,000 subjects will be enrolled at 20 investigation sites within the territory of China. All subjects enrolled will receive permanent pacemaker implantation or cardiac resynchronization therapy (CRT), and LBBaP will also be performed on them for trial. They will be followed up at pre-hospital discharge, and 1 month and 12 months post-procedure. Data collected in the investigation will be analyzed to assess the effectiveness and safety of LBBaP with Solia S and Selectra 3D in the Chinese population.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Keping, Doctor principal investigator
Fu Wai Hospital, Chinese Academy of Medical Sciences, Fu Wai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consented to Participate in the Trial and Signed an ICF and Patients With an Indication for PM Implantation or CRTP, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Keping, Doctor (13811266140 ext. +86, chenkepingfw@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation success rate of LBBaP (time frame: During the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.