Atrioventricular Nodal DiseaseNCT05129098
Left Bundle Branch Pacing Versus Conventional Pacing in Atrioventricular Block
A study testing Left bundle branch pacing lead (Select Secure 3830 lead) and Right ventricular active fixation lead in people with Atrioventricular Nodal Disease, run by University Hospital of Patras at 1 site in Greece.
Trial summary
Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrioventricular Nodal Disease
- What is being tested?
- Left bundle branch pacing lead (Select Secure 3830 lead) and Right ventricular active fixation lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGreece
- Study dates
- 13 Jul 2021to 20 Dec 2022
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years old
- Patients with atrioventricular block and EF>50% with a predicted ventricular pacing rate>20%
- Patients with intraventricular septal diameter>8mm
- Written informed consent
Who cannot join
- Indication for CRT or ICD device
- Patients with no subclavian approach, who are candidates for leadless devices
- Presence of severe tricuspid regurgitation
- Patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Bundle Branch Pacing Versus Conventional Pacing in Patients With Atrioventricular Node Disorders: a Randomized, Control Study
Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.
Read the detailed description
In this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared In recent years, His pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. An alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. The randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months and one year post-procedure.
- Conditions
- Atrioventricular Nodal Disease
- Being tested
- Left bundle branch pacing lead (Select Secure 3830 lead), Right ventricular active fixation lead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left bundle branch pacing lead (Select Secure 3830 lead)Device
Implantation of a left bundle branch pacing lead via sheath
Right ventricular active fixation leadDevice
Active fixation lead (standard)
| Study group | Role | What they receive |
|---|---|---|
| Left Bundle Branch Pacing | Experimental | Implantation of a left bundle branch lead via sheath, to perform left bundle branch pacing Receives: Device: Left bundle branch pacing lead (Select Secure 3830 lead) |
| Conventional Right Venticular Pacing | Active comparator | The ventricular lead will be implanted in the right ventricle in the conventional way Receives: Device: Right ventricular active fixation lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the global left ventricular work efficiency- as a measure of dyssynchrony- will be recorded.
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Secondary outcomes (20)
Procedure Time (min)
The total time required for the completion of the procedure
Measured: 1 Day of procedure
Fluoroscopy Time (min)
The total time of fluoroscopy
Measured: 1 Day of procedure
Dose Area Product (DAP) (cGy/cm2)
Total Radiation Dose as expressed with DAP
Measured: 1 Day of procedure
Implant success
Successful implantation with pacing threshold<2 V
Measured: 1 Day of procedure
Complications associated with pacemaker implantation
General device related complications: pneumothorax, hemothorax, infection, tamponade, hematoma, lead reoperation Specific complications associated with the left bundle branch pacing procedure: intraventricular septum rupture, septal perforator branch injury with subsequent myocardial infarction or lead displacement
Measured: through study completion at 1 year post randomisation
B natriuretic peptide measurement (pg/ml)
Blood samples are extracted in all patients at baseline, 3 months, 6 months and one year after the procedure
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Stroke volume index (SVi) (ml/m2)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the SVi will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Ejection Fraction (EF) (%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the EF will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Longitudinal Strain (GLS) (%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the GLS will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain (%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain Rate (1/s)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the Left Atrium Strain Rate will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Aortic Time- Velocity Integral (TVI) (cm)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the aortic TVI will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Work Index (GWI) (mmHg%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWI will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Constructive Work (GCW) (mmHg%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GCW will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Wasted Work (GWW) (mmHg%)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and GWW will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the mid septal wall
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the mid septal wall will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the basal lateral wall
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and segmental WI, CW, WW at the basal lateral wall will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Peak Strain Dispersion (PSD) (msec)
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and PSD will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in capture threshold (V) in the ventricular lead
The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and the potential changes in capture threshold in the ventricular lead will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in sense (mV) in the ventricular lead
The device will be interrogated at baseline, 3 months, 6 months and one year after the procedure and potential changes in sense in the ventricular lead will be recorded
Measured: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start13 Jul 2021
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular Nodal DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Leventopoulos, University Hospital of Patras
- Investigators
- Georgios Leventopoulos, MD, PhD, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129098
- Sponsor's protocol ID
- 251/10-05-21
- Status last verified
- Oct 2023
- First submitted
- 29 Oct 2021
- Last updated
- 27 Oct 2023
- 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Branch Pacing Versus Conventional Pacing in Patients With Atrioventricular Node Disorders: a Randomized, Control Study
- ClinicalTrials.gov ID
- NCT05129098
- Acronym / sponsor ID
- 251/10-05-21
- Conditions
- Atrioventricular Nodal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 22 Nov 2021 (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.
Recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. Left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.
Detailed description
In this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared In recent years, His pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3D mapping. However, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. An alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. The lead implantation of LBB pacing is performed using the Select Secure (3830) pacing lead. The lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. The randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. Follow-up is conducted at 3 months, 6 months and one year post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Bundle Branch Pacing | Experimental | Device: Left bundle branch pacing lead (Select Secure 3830 lead)Implantation of a left bundle branch lead via sheath, to perform left bundle branch pacing |
| Conventional Right Venticular Pacing | Active comparator | Device: Right ventricular active fixation leadThe ventricular lead will be implanted in the right ventricle in the conventional way |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18 years old
- Patients with atrioventricular block and EF>50% with a predicted ventricular pacing rate>20%
- Patients with intraventricular septal diameter>8mm
- Written informed consent
Key exclusion criteria (4 listed)
- Indication for CRT or ICD device
- Patients with no subclavian approach, who are candidates for leadless devices
- Presence of severe tricuspid regurgitation
- Patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations
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 lead (Select Secure 3830 lead)Implantation of a left bundle branch pacing lead via sheath | Device | Left Bundle Branch Pacing |
| Right ventricular active fixation leadActive fixation lead (standard) | Device | Conventional Right Venticular Pacing |
Primary outcome
Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Follow-up transthoracic echocardiography will be held 24 hours, 3 months, 6 months and one year after the procedure and the global left ventricular work efficiency- as a measure of dyssynchrony- will be recorded.
20 secondary outcomes
Procedure Time (min)
Time frame: 1 Day of procedure
Fluoroscopy Time (min)
Time frame: 1 Day of procedure
Dose Area Product (DAP) (cGy/cm2)
Time frame: 1 Day of procedure
Implant success
Time frame: 1 Day of procedure
Complications associated with pacemaker implantation
Time frame: through study completion at 1 year post randomisation
B natriuretic peptide measurement (pg/ml)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Stroke volume index (SVi) (ml/m2)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Ejection Fraction (EF) (%)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Longitudinal Strain (GLS) (%)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain (%)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Left Atrium Strain Rate (1/s)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Aortic Time- Velocity Integral (TVI) (cm)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Work Index (GWI) (mmHg%)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Constructive Work (GCW) (mmHg%)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Global Wasted Work (GWW) (mmHg%)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the mid septal wall
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Segmental CW, WW at the basal lateral wall
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Peak Strain Dispersion (PSD) (msec)
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in capture threshold (V) in the ventricular lead
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
Changes in sense (mV) in the ventricular lead
Time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure
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 27 Oct 2023.
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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.
Georgios Leventopoulos, MD, PhD principal investigator
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left bundle branch pacing lead (Select Secure 3830 lead) and Right ventricular active fixation lead in people with Atrioventricular Nodal Disease, run by University Hospital of Patras at 1 site in Greece.
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 4 inclusion and 4 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 27 Oct 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 Greece. 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?
Echocardiographic dyssynchrony index, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%) (time frame: 24 hours after the procedure as baseline and change at 3 months, 6 months and one year post-procedure). 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 27 Oct 2023.