AVB - Atrioventricular BlockNCT05722379
Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block
An observational study of AVB - Atrioventricular Block, run by West China Hospital at 1 site in China.
Trial summary
Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AVB - Atrioventricular Block
- What is being tested?
- left bundle branch pacing (LBBP) and Right ventricular pacing (RVP)
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Apr 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutively high-grade AVB patients undergoing permanent pacemaker implantations from the 1 s t of January 2018 to the 18 thof November 2021 at West China Hospital
Who may be able to join
- included consecutively high-grade AVB patients undergoing permanent pacemaker implantations from the 1 s t of January 2018 to the 18 thof November 2021 at West China Hospital
Who cannot join
- patients with pacemaker replacements were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Sichuan, Sichuan, 610041
Junyan Zhang, 18848242671
About this study
Official title: Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block: an Observational Cohort Study
Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.
Read the detailed description
Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs. However, clinical studies have shown that RVP can cause electrical and mechanical dyssynchrony of the left ventricle and increase the risks of cardiac insufficiency, atrial fibrillation (AF) and death. Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.
- Conditions
- AVB - Atrioventricular Block
- Being tested
- left bundle branch pacing (LBBP), Right ventricular pacing (RVP)
- Keywords
- Left bundle branch pacing, Right ventricular pacing, Mortality, Systolic dyssynchrony
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left bundle branch pacing (LBBP)Procedure or surgery
After recording the His potential, the 3830-69 lead (Medtronic Inc., Minneapolis, MN USA) was sent 1-2 cm forward and downward to find the insertion point of the right side of intra-ventricular septum combined with the pre-rotation impedance and ECG changes. Ultimately, the tip was perpendicularly straightforward posited against the septum to the left septal side .
Right ventricular pacing (RVP)Procedure or surgery
Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs.
| Study group | Role | What they receive |
|---|---|---|
| high-grade AVB patients undergoing permanent pacemaker implantations | Not described Receives: Procedure: left bundle branch pacing (LBBP); Procedure: Right ventricular pacing (RVP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups
composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups
Measured: through study completion, an average of 2.45 year
Lead failure
reintervention for increased pacing thresholds, lead dislocation or ventricular perforation after the initial implantation procedure
Measured: through study completion, an average of 2.45 year
HFH
HFH was defined as the admission to hospital for >24 hours with worsening symptoms and signs of heart failure and requiring one or more intravenous diuretics or intravenous inotropic medications
Measured: through study completion, an average of 2.45 year
Secondary outcomes (3)
peri-procedure complication
included pericardial tamponade and pneumothorax
Measured: through study completion, an average of 2.45 year
cardiac death
documented arrhythmogenic death, an unexpected presumed pulseles condition with the absence of an obvious noncardiac explanation, or a death due to congestive cardiac failure or structural heart disease
Measured: through study completion, an average of 2.45 year
recurrent unexplained syncope
recurrent unexplained syncope
Measured: through study completion, an average of 2.45 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jan 2023
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AVB - Atrioventricular BlockStudies of the same condition, open and under way.
- More trials run by West China 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongxiu Chen, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722379
- Sponsor's protocol ID
- WestChinaH-LBBP-001
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen Z, Xu Y, Jiang L, Zhang R, Zhao H, Liu R, Zhang L, Li Y, Liu X. Left Bundle Branch Area Pacing versus Right Ventricular Pacing in Patients with Atrioventricular Block: An Observational Cohort Study. Cardiovasc Ther. 2023 Aug 21;2023:6659048. doi: 10.1155/2023/6659048. eCollection 2023.
PubMed 37645544
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Block: an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05722379
- Acronym / sponsor ID
- WestChinaH-LBBP-001
- Conditions
- AVB - Atrioventricular Block
- Keywords
- Left bundle branch pacing, Right ventricular pacing, Mortality, Systolic dyssynchrony
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 10 Feb 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.
Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.
Detailed description
Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs. However, clinical studies have shown that RVP can cause electrical and mechanical dyssynchrony of the left ventricle and increase the risks of cardiac insufficiency, atrial fibrillation (AF) and death. Although emerging evidence demonstrated that left bundle branch pacing (LBBP) is a promising alternative for patients with either a bradycardia or a heart failure pacing indication. However, a direct comparison of the safety, efficacy and LV systolic synchrony between LBBP and RVP regimens was rare. In this study, the investigators aim to conduct a comparison of the safety and effectiveness performance between these two pacing methods for patients with atrioventricular block (AVB). The investigators focused on AVB patients undergoing permanent pacemaker implantations from the 1st of January 2018 to the 18th of November 2021 at West China Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-grade AVB patients undergoing permanent pacemaker implantations | – | Procedure: left bundle branch pacing (LBBP), Procedure: Right ventricular pacing (RVP) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutively high-grade AVB patients undergoing permanent pacemaker implantations from the 1 s t of January 2018 to the 18 thof November 2021 at West China Hospital
Key inclusion criteria (1 listed)
- included consecutively high-grade AVB patients undergoing permanent pacemaker implantations from the 1 s t of January 2018 to the 18 thof November 2021 at West China Hospital
Key exclusion criteria (1 listed)
- patients with pacemaker replacements were excluded.
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 |
|---|---|---|
| left bundle branch pacing (LBBP)After recording the His potential, the 3830-69 lead (Medtronic Inc., Minneapolis, MN USA) was sent 1-2 cm forward and downward to find the insertion point of the right side of intra-ventricular septum combined with the pre-rotation impedance and ECG changes. Ultimately, the tip was perpendicularly straightforward posited against the septum to the left septal side . | Procedure or surgery | high-grade AVB patients undergoing permanent pacemaker implantations |
| Right ventricular pacing (RVP)Right ventricular pacing (RVP) is the standard treatment for patients with continuous ventricular pacing needs. | Procedure or surgery | high-grade AVB patients undergoing permanent pacemaker implantations |
Primary outcome
composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups
Time frame: through study completion, an average of 2.45 year
composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups
Lead failure
Time frame: through study completion, an average of 2.45 year
reintervention for increased pacing thresholds, lead dislocation or ventricular perforation after the initial implantation procedure
HFH
Time frame: through study completion, an average of 2.45 year
HFH was defined as the admission to hospital for >24 hours with worsening symptoms and signs of heart failure and requiring one or more intravenous diuretics or intravenous inotropic medications
3 secondary outcomes
peri-procedure complication
Time frame: through study completion, an average of 2.45 year
cardiac death
Time frame: through study completion, an average of 2.45 year
recurrent unexplained syncope
Time frame: through study completion, an average of 2.45 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Derived from this study: PubMed 37645544Chen Z, Xu Y, Jiang L, Zhang R, Zhao H, Liu R, Zhang L, Li Y, Liu X. Left Bundle Branch Area Pacing versus Right Ventricular Pacing in Patients with Atrioventricular Block: An Observational Cohort Study. Cardiovasc Ther. 2023 Aug 21;2023:6659048. doi: 10.1155/2023/6659048. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 AVB - Atrioventricular Block, run by West China 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: status not confirmed, as of the sponsor's last update on 10 Feb 2023. 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 Zhongxiu Chen, Dr (18030708238, 619087296@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composed of all-cause mortality, lead failure and heart failure hospitalization (HFH) during the follow-ups (time frame: through study completion, an average of 2.45 year). 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?
On the ClinicalTrials.gov record for NCT05722379, which also lists 1 linked publication.
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 10 Feb 2023.