Heart FailureNCT06540521
Bolt CSP-M Holter Study
An observational study of Heart Failure and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites in China.
Trial summary
The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Bradycardia
- How many people
- 95 participants
- Where
- 2 sitesChina
- Study dates
- 13 Aug 2024to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study selected two study site in China. One is a Tertiary A hospital in Shanghai, and another is a cardiovascular specialty hospital in Zhejiang Province. Both the two sites locate in the south east of China. This study will enroll 70 subjects who meet all the inclusion and exclusion criteria from the patients who have received LBBAP therapies from the two hospitals.
Who may be able to join
- Patients aged >=18 years
- Patients who are willing to provide Informed Consent
- Patients who have received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month)
- Patients implanted with a single/dual-chamber pacemaker or a CRT-P with LBBAP lead connected to RV port
- Implanted device can provide at least 3-channel real-time intracardiac electrogram
Who cannot join
- Patients who are pregnant or have a plan for pregnancy during the study
- Patients who have medical conditions that would limit study participation
- Patients who were already enrolled in clinical trial(s) which would impact study participation
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhejiang Greentown Cardiovascular Hospital
Hangzhou, Zhejiang
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
About this study
Official title: Intracardiac Electrical Characteristics of LBBAP
The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.
Read the detailed description
Among LBB area pacing (LBBAP), it has been reported that left ventricular (LV) septal pacing (LVSP), which refers to a pacing approach that only captures the LV septal myocardium, produces homogeneous electrical propagation in the septum and leads to delayed LV lateral wall activation. Although large randomized trials are lacking, small observational studies have shown more preserved physiological ventricular depolarization, or superior electrical and mechanical synchrony of the LBB capture over LVSP.
During the implantation of a device, the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs. A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold (PCT) of the local myocardium is different from that of the LBB (i.e., LBB-PCT), indicating a transition between capturing the LBB and LVSP without any LBB capture. So far, there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status. Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture.
- Conditions
- Heart Failure, Bradycardia
- Being tested
- No intervention
- Keywords
- LBBAP, LBBP, LVSP
- Medical subject headings
- Heart Failure, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracardiac electrical characteristics in different pacing outputs.
12-lead ECG and LBBAP EGM characteristics and duration in different pacing outputs.
Measured: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment
Secondary outcomes (2)
Intracardiac electrical characteristics under different body position.
12-lead ECG and LBBAP EGM characteristics and duration under different body positions.
Measured: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment
The correlation between LBB capture status and LBBAP EGM characteristics
ECG and EGM characteristics in different LBB capture status
Measured: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start13 Aug 2024
- Primary completion11 Feb 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540521
- Sponsor's protocol ID
- MDT24030
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang 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 29173611Chen X, Qian Z, Zou F, Wang Y, Zhang X, Qiu Y, Hou X, Zhou X, Vijayaraman P, Zou J. Differentiating left bundle branch pacing and left ventricular septal pacing: An algorithm based on intracardiac electrophysiology. J Cardiovasc Electrophysiol. 2022 Mar;33(3):448-457. doi: 10.1111/jce.15350. Epub 2022 Jan 12.
PubMed 34978368Zhou Y, Wang J, Wei Y, Zhang W, Yang Y, Rui S, Ju C. Left ventricular septal pacing versus left bundle branch pacing in the treatment of atrioventricular block. Ann Noninvasive Electrocardiol. 2022 May;27(3):e12944. doi: 10.1111/anec.12944. Epub 2022 Mar 10.
PubMed 35267228Wu S, Chen X, Wang S, Xu L, Xiao F, Huang Z, Zheng R, Jiang L, Vijayaraman P, Sharma PS, Su L, Huang W. Evaluation of the Criteria to Distinguish Left Bundle Branch Pacing From Left Ventricular Septal Pacing. JACC Clin Electrophysiol. 2021 Sep;7(9):1166-1177. doi: 10.1016/j.jacep.2021.02.018. Epub 2021 Apr 28.
PubMed 33933414
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracardiac Electrical Characteristics of LBBAP
- ClinicalTrials.gov ID
- NCT06540521
- Acronym / sponsor ID
- MDT24030
- Conditions
- Heart Failure, Bradycardia
- Keywords
- LBBAP, LBBP, LVSP
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 6 Aug 2024 (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.
The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.
Detailed description
Among LBB area pacing (LBBAP), it has been reported that left ventricular (LV) septal pacing (LVSP), which refers to a pacing approach that only captures the LV septal myocardium, produces homogeneous electrical propagation in the septum and leads to delayed LV lateral wall activation. Although large randomized trials are lacking, small observational studies have shown more preserved physiological ventricular depolarization, or superior electrical and mechanical synchrony of the LBB capture over LVSP.
During the implantation of a device, the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs. A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold (PCT) of the local myocardium is different from that of the LBB (i.e., LBB-PCT), indicating a transition between capturing the LBB and LVSP without any LBB capture. So far, there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status. Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study selected two study site in China. One is a Tertiary A hospital in Shanghai, and another is a cardiovascular specialty hospital in Zhejiang Province. Both the two sites locate in the south east of China. This study will enroll 70 subjects who meet all the inclusion and exclusion criteria from the patients who have received LBBAP therapies from the two hospitals.
Key inclusion criteria (5 listed)
- Patients aged >=18 years
- Patients who are willing to provide Informed Consent
- Patients who have received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month)
- Patients implanted with a single/dual-chamber pacemaker or a CRT-P with LBBAP lead connected to RV port
- Implanted device can provide at least 3-channel real-time intracardiac electrogram
Key exclusion criteria (3 listed)
- Patients who are pregnant or have a plan for pregnancy during the study
- Patients who have medical conditions that would limit study participation
- Patients who were already enrolled in clinical trial(s) which would impact study participation
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Intracardiac electrical characteristics in different pacing outputs.
Time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment
12-lead ECG and LBBAP EGM characteristics and duration in different pacing outputs.
2 secondary outcomes
Intracardiac electrical characteristics under different body position.
Time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment
The correlation between LBB capture status and LBBAP EGM characteristics
Time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- 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 34978368Chen X, Qian Z, Zou F, Wang Y, Zhang X, Qiu Y, Hou X, Zhou X, Vijayaraman P, Zou J. Differentiating left bundle branch pacing and left ventricular septal pacing: An algorithm based on intracardiac electrophysiology. J Cardiovasc Electrophysiol. 2022 Mar;33(3):448-457. doi: 10.1111/jce.15350. Epub 2022 Jan 12.
- Background: PubMed 35267228Zhou Y, Wang J, Wei Y, Zhang W, Yang Y, Rui S, Ju C. Left ventricular septal pacing versus left bundle branch pacing in the treatment of atrioventricular block. Ann Noninvasive Electrocardiol. 2022 May;27(3):e12944. doi: 10.1111/anec.12944. Epub 2022 Mar 10.
- Background: PubMed 33933414Wu S, Chen X, Wang S, Xu L, Xiao F, Huang Z, Zheng R, Jiang L, Vijayaraman P, Sharma PS, Su L, Huang W. Evaluation of the Criteria to Distinguish Left Bundle Branch Pacing From Left Ventricular Septal Pacing. JACC Clin Electrophysiol. 2021 Sep;7(9):1166-1177. doi: 10.1016/j.jacep.2021.02.018. Epub 2021 Apr 28.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 2 sites 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Intracardiac electrical characteristics in different pacing outputs. (time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment). 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 NCT06540521, which also lists 4 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 16 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.