Atrio-Ventricular BlockNCT06674967
Efficacy and Safety of Left Bundle Area Pacing Vs Right Ventricular Apical Pacing in Patients with Atrioventricular Block
An observational study of Atrio-Ventricular Block, run by Assiut University at 1 site in Egypt.
Trial summary
This study will address whether LBBaP is superior to RVAP in terms of safety and efficacy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrio-Ventricular Block
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2024to 1 Aug 2027
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: . Patients with AVB who meet indications for pacemaker , with an estimated percentage of ventricular pacing ≥50%
Who may be able to join
- Patients with AVB who meet indications for pacemaker
- Implantation with an estimated percentage of ventricular pacing ≥50%
- Ability to provide informed consent
Who cannot join
- Failure to cooperate with follow-up.
- Persistent atrial fibrillation.
- Patients with heart failure (LVEF) ≤35%,
- Estimated glomerular filtration rate less than 30 ml/min.
- Septic shock
- advanced malignant tumor.
- Pregnancy or prepared to get pregnant
- Cardiac tamponade or major hemopericardium
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university
Asyut, Asyut Governorate, 71515
Karim Mohamed Aly, Assistant lecturer, 00201068545195, karimeltaher294@aun.edu.eg
About this study
This study will address whether LBBaP is superior to RVAP in terms of safety and efficacy
Read the detailed description
- Cardiac pacing is an effective therapy for treating patients with bradycardia due to sinus node dysfunction or atrioventricular block. However, traditional right ventricular apical pacing (RVAP) causes electric and mechanical desynchrony, increasing the risk for atrial arrhythmias and heart failure.
- .Cardiac resynchronization therapy(CRT)is another pacing modality employed for treatment of HF .Clinical studies have demonstrated that CRT promotes left ventricular reverse remodelling and reduces morbidity and mortality in patients with HF . Although CRT's benefits are well demonstrated, the therapy has been associated with significantly high non-response rate(30-40%).Also, the BVP is a non-physiological approach that requires two leads to activate the ventricular myocardium and not the specialized conduction system
- Therefore, there is a need to develop a physiological pacing approach that provides synchronized contraction of the ventricles
- Although His bundle pacing (HBP)has been widely used as a physiological pacing modality, it is limited by challenging implantation technique, unsatisfactory success rate in patients with wide QRS wave, high pacing capture threshold, and early battery depletion.
- Recently, the left bundle branch pacing (LBBP), defined as the capture of the left bundle branch (LBB) via trans ventricular septal approach, has emerged as a new physiological pacing modality.
- this approach has been found to provide physiological pacing that guarantees electrical synchrony of the left ventricle with a low pacing threshold.
- LBBP implantation is done by The Select Secure lead (model 3830) and Select Site C315HisorC304His sheaths are used in operation, while an electrophysiological multichannel recorder is used to simultaneously document intracardiac EGMs and 12-lead ECG .the Pacing System Analyzer (PSA) is used to test the pacing parameters and record intracardiac EGMs. The operation process can be summarized as follows: (1) establishment of the venous access and determination of the initial LBBP site; (2) introducing a pacing lead into the right ventricle and screwing it into the interventricular septum(IVS) until it reached in the LBB areas;(3) assessing the lead depth into ventricular septum and confirming LBB capture; (4)removing the sheath and providing the slack; and(5)programming the pulse generator.
- There is a limited number of clinical studies, featuring small sample sizes, that have shown that, compared with right ventricular apex pacing (RVAP), the QRS duration of postoperative ECG in LBBaP patients is narrower and the cardiac systolic function is improved. Also, there have been limited number of randomized controlled trials (RCTs) evaluating the efficacy and safety of LBBaP in patients with atrioventricular block (AVB) versus those with RVAP.
- Conditions
- Atrio-Ventricular Block
- Keywords
- Efficacy, Safety, RV apical pacing, LBB area pacing, Atrioventricular block
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LBB area pacing group | study group with LBB area pacing | |
| RV apical pacing area | study group with RV apical pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness with LBB pacing
Assess left ventricular global strain using speckle tracking echocardiography (percentage)
Measured: 3 years
Incidence of adverse events in patient with LBB pacing
Malignant arrhythmia(Yes/No)
Measured: 3 years
Incidence of septal perforation
Detect septal perforation(Yes/No)
Measured: 3 years
Secondary outcomes (1)
Major Adverse Cardiovascular Events
- All-cause mortality (Yes or No) cardiovascular deaths (Yes or No) rehospitalisation with heart failure (Yes or No) Lead dislocation (Yes or No) Lead infection. (Yes or No)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrio-Ventricular BlockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prospective
- Enrolment
- 42 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Mohamed Eltaher Abdelrahman Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674967
- Sponsor's protocol ID
- LBB pacing vs RV pacing in AVB
- Status last verified
- Nov 2024
- First submitted
- 14 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Left Bundle Area Pacing Vs Right Ventricular Apical Pacing in Patients with Atrioventricular Block
- ClinicalTrials.gov ID
- NCT06674967
- Acronym / sponsor ID
- LBB pacing vs RV pacing in AVB
- Conditions
- Atrio-Ventricular Block
- Keywords
- Efficacy, Safety, RV apical pacing, LBB area pacing, Atrioventricular block
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 5 Nov 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.
This study will address whether LBBaP is superior to RVAP in terms of safety and efficacy
Detailed description
- Cardiac pacing is an effective therapy for treating patients with bradycardia due to sinus node dysfunction or atrioventricular block. However, traditional right ventricular apical pacing (RVAP) causes electric and mechanical desynchrony, increasing the risk for atrial arrhythmias and heart failure.
- .Cardiac resynchronization therapy(CRT)is another pacing modality employed for treatment of HF .Clinical studies have demonstrated that CRT promotes left ventricular reverse remodelling and reduces morbidity and mortality in patients with HF . Although CRT's benefits are well demonstrated, the therapy has been associated with significantly high non-response rate(30-40%).Also, the BVP is a non-physiological approach that requires two leads to activate the ventricular myocardium and not the specialized conduction system
- Therefore, there is a need to develop a physiological pacing approach that provides synchronized contraction of the ventricles
- Although His bundle pacing (HBP)has been widely used as a physiological pacing modality, it is limited by challenging implantation technique, unsatisfactory success rate in patients with wide QRS wave, high pacing capture threshold, and early battery depletion.
- Recently, the left bundle branch pacing (LBBP), defined as the capture of the left bundle branch (LBB) via trans ventricular septal approach, has emerged as a new physiological pacing modality.
- this approach has been found to provide physiological pacing that guarantees electrical synchrony of the left ventricle with a low pacing threshold.
- LBBP implantation is done by The Select Secure lead (model 3830) and Select Site C315HisorC304His sheaths are used in operation, while an electrophysiological multichannel recorder is used to simultaneously document intracardiac EGMs and 12-lead ECG .the Pacing System Analyzer (PSA) is used to test the pacing parameters and record intracardiac EGMs. The operation process can be summarized as follows: (1) establishment of the venous access and determination of the initial LBBP site; (2) introducing a pacing lead into the right ventricle and screwing it into the interventricular septum(IVS) until it reached in the LBB areas;(3) assessing the lead depth into ventricular septum and confirming LBB capture; (4)removing the sheath and providing the slack; and(5)programming the pulse generator.
- There is a limited number of clinical studies, featuring small sample sizes, that have shown that, compared with right ventricular apex pacing (RVAP), the QRS duration of postoperative ECG in LBBaP patients is narrower and the cardiac systolic function is improved. Also, there have been limited number of randomized controlled trials (RCTs) evaluating the efficacy and safety of LBBaP in patients with atrioventricular block (AVB) versus those with RVAP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBB area pacing group | – | –study group with LBB area pacing |
| RV apical pacing area | – | –study group with RV apical pacing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- . Patients with AVB who meet indications for pacemaker , with an estimated percentage of ventricular pacing ≥50%
Key inclusion criteria (3 listed)
- Patients with AVB who meet indications for pacemaker
- Implantation with an estimated percentage of ventricular pacing ≥50%
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- Failure to cooperate with follow-up.
- Persistent atrial fibrillation.
- Patients with heart failure (LVEF) ≤35%,
- Estimated glomerular filtration rate less than 30 ml/min.
- Septic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effectiveness with LBB pacing
Time frame: 3 years
Assess left ventricular global strain using speckle tracking echocardiography (percentage)
Incidence of adverse events in patient with LBB pacing
Time frame: 3 years
Malignant arrhythmia(Yes/No)
Incidence of septal perforation
Time frame: 3 years
Detect septal perforation(Yes/No)
1 secondary outcome
Major Adverse Cardiovascular Events
Time frame: 3 years
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 5 Nov 2024.
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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.
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 Atrio-Ventricular Block, run by Assiut University at 1 site in Egypt.
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 8 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: opening soon, as of the sponsor's last update on 5 Nov 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness with LBB pacing (time frame: 3 years). 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 5 Nov 2024.