Atrioventricular BlockNCT05600699
Long-term Efficacy and Safety Research of Left Bundle Branch Pacing
An observational study of Atrioventricular Block and Left Bundle Branch Pacing, run by Linyi People's Hospital at 1 site in China.
Trial summary
Patients with successful left bundle branch pacing in our center were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Atrioventricular Block, Left Bundle Branch Pacing
- What is being tested?
- Cardiac pacemaker and Select Secure lead
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 1 Oct 2022
- How long will I take part?
- 3 Years
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From April 2018 to Dec 2019, consecutive patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study. Main indications for the enrolment of patients are atrioventricular block and heart failure (HF) combined with complete left bundle branch block (LBBB). All patients were accorded with indications for pacing therapy of 2013 European Society of Cardiology guidelines on cardiac pacing. The study conforms to the guiding principles of the Declaration of Helsinki and was approved by Ethics Committee of the Linyi People's Hospital. All patients signed the informed consent.
Who may be able to join
- Patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study
Who cannot join
- Low rate of pacing, and loss to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Patients with successful left bundle branch pacing in our center were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group; Purkinje potential group; and no-potential group. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.
Read the detailed description
A total of 136 patients with a high percentage of ventricular pacing and successful left bundle branch pacing were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group (L group) 31.6%; Purkinje potential group (P group) 10.3%; and no-potential group (N group) 58.1%. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.
- Conditions
- Atrioventricular Block, Left Bundle Branch Pacing
- Being tested
- Cardiac pacemaker and Select Secure lead
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac pacemaker and Select Secure leadDevice
model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA
| Study group | Role | What they receive |
|---|---|---|
| left bundle branch potential group | the left bundle branch potential was recorded at implantation Receives: Device: Cardiac pacemaker and Select Secure lead | |
| Purkinje potential group | the purkinje potential was recorded at implantation Receives: Device: Cardiac pacemaker and Select Secure lead | |
| no-potential group | no potential was recorded at implantation Receives: Device: Cardiac pacemaker and Select Secure lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in left atrium diameter at 3 years
Echocardiography is measured by a professional using an ultrasound machine, record the following results: left atrium diameter (ms)
Measured: Baseline and 3 years
Change from Baseline in left ventricular end diastolic diameter at 3 years
Left ventricular end diastolic diameter (ms)
Measured: Baseline and 3 years
Change from Baseline in left ventricular ejection fraction at 3 years
Left ventricular ejection fraction (%)
Measured: Baseline and 3 years
Change from Baseline in pulmonary artery systolic pressure at 3 years
Pulmonary artery systolic pressure (mmHg)
Measured: Baseline and 3 years
Secondary outcomes (2)
Change from Baseline in threshold at 3 years
Threshold was measured with a pace-sensing analyser: threshold (V) at 0.5ms
Measured: Baseline and 3 years
Change from Baseline in impedance at 3 years
Impedance was measured with a pace-sensing analyser: impedance(Ω)
Measured: Baseline and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Apr 2018
- Primary completion31 Dec 2019
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular BlockStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Linyi People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinhua Li, Linyi People's Hospital
- Investigators
- Fingming Li, Study chair, Linyi People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600699
- Sponsor's protocol ID
- Linyi People's Hospital
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: all collected IPD would be shared after publishing
Publications
Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.
PubMed 31233818Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.
PubMed 29173611Su L, Wang S, Wu S, Xu L, Huang Z, Chen X, Zheng R, Jiang L, Ellenbogen KA, Whinnett ZI, Huang W. Long-Term Safety and Feasibility of Left Bundle Branch Pacing in a Large Single-Center Study. Circ Arrhythm Electrophysiol. 2021 Feb;14(2):e009261. doi: 10.1161/CIRCEP.120.009261. Epub 2021 Jan 9.
PubMed 33426907Hou X, Qian Z, Wang Y, Qiu Y, Chen X, Jiang H, Jiang Z, Wu H, Zhao Z, Zhou W, Zou J. Feasibility and cardiac synchrony of permanent left bundle branch pacing through the interventricular septum. Europace. 2019 Nov 1;21(11):1694-1702. doi: 10.1093/europace/euz188.
PubMed 31322651Ponnusamy SS, Muthu G, Kumar M, Bopanna D, Anand V, Kumar S. Mid-term feasibility, safety and outcomes of left bundle branch pacing-single center experience. J Interv Card Electrophysiol. 2021 Mar;60(2):337-346. doi: 10.1007/s10840-020-00807-w. Epub 2020 Jul 4.
PubMed 32623624
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy and Safety Research of Left Bundle Branch Pacing
- ClinicalTrials.gov ID
- NCT05600699
- Acronym / sponsor ID
- Linyi People's Hospital
- Conditions
- Atrioventricular Block, Left Bundle Branch Pacing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Linyi People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 31 Oct 2022 (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.
Patients with successful left bundle branch pacing in our center were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group; Purkinje potential group; and no-potential group. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.
Detailed description
A total of 136 patients with a high percentage of ventricular pacing and successful left bundle branch pacing were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group (L group) 31.6%; Purkinje potential group (P group) 10.3%; and no-potential group (N group) 58.1%. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| left bundle branch potential group | – | Device: Cardiac pacemaker and Select Secure leadthe left bundle branch potential was recorded at implantation |
| Purkinje potential group | – | Device: Cardiac pacemaker and Select Secure leadthe purkinje potential was recorded at implantation |
| no-potential group | – | Device: Cardiac pacemaker and Select Secure leadno potential was recorded at implantation |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From April 2018 to Dec 2019, consecutive patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study. Main indications for the enrolment of patients are atrioventricular block and heart failure (HF) combined with complete left bundle branch block (LBBB). All patients were accorded with indications for pacing therapy of 2013 European Society of Cardiology guidelines on cardiac pacing. The study conforms to the guiding principles of the Declaration of Helsinki and was approved by Ethics Committee of the Linyi People's Hospital. All patients signed the informed consent.
Key inclusion criteria (1 listed)
- Patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study
Key exclusion criteria (1 listed)
- Low rate of pacing, and loss to follow-up
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 |
|---|---|---|
| Cardiac pacemaker and Select Secure leadmodel 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA | Device | Purkinje potential group, left bundle branch potential group, no-potential group |
Primary outcome
Change from Baseline in left atrium diameter at 3 years
Time frame: Baseline and 3 years
Echocardiography is measured by a professional using an ultrasound machine, record the following results: left atrium diameter (ms)
Change from Baseline in left ventricular end diastolic diameter at 3 years
Time frame: Baseline and 3 years
Left ventricular end diastolic diameter (ms)
Change from Baseline in left ventricular ejection fraction at 3 years
Time frame: Baseline and 3 years
Left ventricular ejection fraction (%)
Change from Baseline in pulmonary artery systolic pressure at 3 years
Time frame: Baseline and 3 years
Pulmonary artery systolic pressure (mmHg)
2 secondary outcomes
Change from Baseline in threshold at 3 years
Time frame: Baseline and 3 years
Change from Baseline in impedance at 3 years
Time frame: Baseline and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 31233818Huang W, Chen X, Su L, Wu S, Xia X, Vijayaraman P. A beginner's guide to permanent left bundle branch pacing. Heart Rhythm. 2019 Dec;16(12):1791-1796. doi: 10.1016/j.hrthm.2019.06.016. Epub 2019 Jun 22. No abstract available.
- Background: PubMed 29173611Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.
- Background: PubMed 33426907Su L, Wang S, Wu S, Xu L, Huang Z, Chen X, Zheng R, Jiang L, Ellenbogen KA, Whinnett ZI, Huang W. Long-Term Safety and Feasibility of Left Bundle Branch Pacing in a Large Single-Center Study. Circ Arrhythm Electrophysiol. 2021 Feb;14(2):e009261. doi: 10.1161/CIRCEP.120.009261. Epub 2021 Jan 9.
- Background: PubMed 31322651Hou X, Qian Z, Wang Y, Qiu Y, Chen X, Jiang H, Jiang Z, Wu H, Zhao Z, Zhou W, Zou J. Feasibility and cardiac synchrony of permanent left bundle branch pacing through the interventricular septum. Europace. 2019 Nov 1;21(11):1694-1702. doi: 10.1093/europace/euz188.
- Background: PubMed 32623624Ponnusamy SS, Muthu G, Kumar M, Bopanna D, Anand V, Kumar S. Mid-term feasibility, safety and outcomes of left bundle branch pacing-single center experience. J Interv Card Electrophysiol. 2021 Mar;60(2):337-346. doi: 10.1007/s10840-020-00807-w. Epub 2020 Jul 4.
- Individual participant dataSharing planned: Undecided. all collected IPD would be shared after publishing
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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.
Fingming Li study chair
Linyi People's Hospital
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 Atrioventricular Block and Left Bundle Branch Pacing, run by Linyi People's 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in left atrium diameter at 3 years (time frame: Baseline and 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05600699, which also lists 5 linked publications.
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 1 Nov 2022.