Heart Failure With Reduced Ejection Fraction (HFrEF)ECHO-LBBpNCT06689111
Correlation of Typical LBBB Mechanical Activation Pattern by 2D Strain Echocardiography With Acute GWE Improvement in Patients Receiving LBBp or Conventional BiVp for Cardiac Resynchronization Therapy (Echo LBBp)
A study testing Left bundle branch pacing lead and CRT with the standard method through cs in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by University Hospital of Patras at 1 site in Greece.
Trial summary
The present study is a multicenter interventional non randomised study in patients requiring an implantable device for cardiac resynchronization therapy. Its primary objective is to investigate whether the presence of a specific echocardiographic contraction pattern before implantation is associated with increased… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- Left bundle branch pacing lead and CRT with the standard method through cs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 23 May 2024to 30 Nov 2026
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years < 90 years
- Patients with a documented indication for resynchronization therapy [symptomatic patients despite optimal medication, HFrEF (EF<35%), LBBB QRS morphology]
- COMPLETE LBBB (LBBB defined as QRS>130msec, wide "notched or slurred" R wave in leads I, aVL, V5, V6 and occasional RS pattern in V5, V6, absence of Q waves in leads I, V5 and V6 but in lead aVL narrow Q wave may be present in the absence of myocardial pathology, R peak time >60ms in leads V5 and V6 but normal in leads V1, V2, V3 when small R's are discernible in precardial leads, ST and T usually opposite to QRS direction)
- Patients with ntraventricular septum diameter >8 mm
- Written informed consent
Who cannot join
- Patients with RBBB or atypical LBBB QRS morphology
- Patients eligible for an upgrade procedure (already carring a PM or ICD)
- Patients with hypertrophic cardiomyopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Patras
Pátrai, Greece, 26504
Georgios Leventopoulos, MD, PhD, 30 2613603281, levent2669@hotmail.com
About this study
Official title: Investigation of Whether the Presence of the Typical LBBB- Mechanical Stimulation Pattern - Documented Through 2DSE (Two-dimensional Strain Echocardiography) - is Associated With Increased Rates of Acute Improvement in Global Myocardial Work Efficiency (GWE) Compared to the Absence of This Activation Pattern, in Patients in Need of Device Implantation for Cardiac Resynchronization Therapy in Whom LBBp is Chosen Compared to the Classic Biventricular Pacing Method
The present study is a multicenter interventional non randomised study in patients requiring an implantable device for cardiac resynchronization therapy. Its primary objective is to investigate whether the presence of a specific echocardiographic contraction pattern before implantation is associated with increased rates of acute improvement in myocardial function (as measured by an ultrasound) and to compare the improvement in two groups of patients based on the type of pacing (biventricular or left-sided pacing)
Read the detailed description
There is now sufficient evidence that the presence of typical LBBB mechanical stimulation on 2D Strain Echocardiography - and not simply the presence of electrocardiographic criteria - is associated with increased rates of adequate response to resynchronization therapy with implantable CRT relative to patients who met electrocardiographic criteria for LBBB without however, the typical stimulation pattern documented echocardiographically.
Identification criteria of LBBB typical mechanical stimulation in 2DSE are :1) early shortening of at least 1 basal or mid-ventricular segment in the septal wall and early stretching in at least 1 basal or midventricular segment in the lateral wall, 2) early septal peak shortening (within the first 70% of the ejection phase), and 3) lateral wall peak shortening after aortic valve closure.
The absence of one of the three criteria categorizes the patient in the group of atypical LBBB stimulation pattern.
Along with the development of the newest non-invasive imaging methods using ultrasound, the calculation of myocardial work (Myocardial Work) as well as the calculation of GWW (Global Wasted Work), GCW (Global Constructive Work) and GWE (Global Work Efficiency) is possible and can be used as a way of assessing myocardial function, the response to administered treatment (e.g. resynchronization therapy) as well as in the search for patients with the most likely response to a possible treatment.
The purpose of the study is to investigate which patients are most likely to benefit from LBBP pacing. Classic biventricular pacing will be compared with LBB pacing in patients requiring resynchronization with LVEF < 35%. At the same time, the presence or not of a typical LBBB- pattern of mechanical stimulation will be evaluated - documented through 2DSE (Two-dimensional strain echocardiography). - The immediate improvement of GWE in patients with succeeded LBB pacing - as documented by measurements in the electrophysiological laboratory- will be compared to the group of patients with the classical method of biventricular pacing (BiVp) as well as the correlation of the presence of the sonographic pattern of LBBB stimulation compared to the group of patients who do not present this mechanical activation pattern in ultrasound.
- Being tested
- Left bundle branch pacing lead, CRT with the standard method through cs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left bundle branch pacing leadDevice
Use of LBBp Vs the standard method of BiVp in resynchronization therapy
CRT with the standard method through csDevice
standard CRT procedure
| 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 |
| Conventional Bi- Ventricular pacing | Active comparator | Conventional resynchronization therapy using a vein through coronary sinus Receives: Device: CRT with the standard method through cs |
What is being measured
The primary outcome is the main question the study is designed to answer.
GWE IMPROVEMENT
Echocardiographic dyssynchrony index change, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%) Change of myocardial work after LBBP/CRT implantation (correlation before and after)* and comparison in four groups based on the method of resynchronization (LBBp and BiVP) and ultrasound findings: a) Echo pattern typical LBBB b) Echo pattern atypical LBBB
Measured: Comparison in the acute phase after implantation (first to second day after the implantation))
Secondary outcomes (3)
Successful LBB pacing
These include the presentation of R' in V1 and at least on of the following:
- Threshold test: the transition from nonselective LBBP (NS-LBBP) to S-LBBP
- V6RWPT< 80ms
- V6-V1 inter-peak interval >44ms
- Potential- V6RWPT =stim-V6RWPT (+/-10ms)
- QRS transition ns - LBBB to s-LBBB by programmed stimulation S1S2
Measured: first day after the 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: first day after the procedure
Procedure and Fluroscopy time (min)
Total procedure and fluroscopy time
Measured: first day after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start23 May 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Collaborators
- University General Hospital of Heraklion, Ippokrateio General Hospital of Thessaloniki, Onassis Cardiac Surgery Centre, Alexandra Hospital, Athens, Greece, Korgialenio-Benakio Red Cross Hospital, Ippokration General Hospital
- Responsible party
- Principal investigator, Georgios Leventopoulos, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689111
- Sponsor's protocol ID
- 337/23.05.2024
- Acronym
- ECHO-LBBp
- Status last verified
- Nov 2025
- First submitted
- 31 Oct 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Whether the Presence of the Typical LBBB- Mechanical Stimulation Pattern - Documented Through 2DSE (Two-dimensional Strain Echocardiography) - is Associated With Increased Rates of Acute Improvement in Global Myocardial Work Efficiency (GWE) Compared to the Absence of This Activation Pattern, in Patients in Need of Device Implantation for Cardiac Resynchronization Therapy in Whom LBBp is Chosen Compared to the Classic Biventricular Pacing Method
- ClinicalTrials.gov ID
- NCT06689111
- Acronym / sponsor ID
- ECHO-LBBp / 337/23.05.2024
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Collaborators
- University General Hospital of Heraklion, Ippokrateio General Hospital of Thessaloniki, Onassis Cardiac Surgery Centre, Alexandra Hospital, Athens, Greece, Korgialenio-Benakio Red Cross Hospital, Ippokration General Hospital
- Study start
- 23 May 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 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.
The present study is a multicenter interventional non randomised study in patients requiring an implantable device for cardiac resynchronization therapy. Its primary objective is to investigate whether the presence of a specific echocardiographic contraction pattern before implantation is associated with increased rates of acute improvement in myocardial function (as measured by an ultrasound) and to compare the improvement in two groups of patients based on the type of pacing (biventricular or left-sided pacing)
Detailed description
There is now sufficient evidence that the presence of typical LBBB mechanical stimulation on 2D Strain Echocardiography - and not simply the presence of electrocardiographic criteria - is associated with increased rates of adequate response to resynchronization therapy with implantable CRT relative to patients who met electrocardiographic criteria for LBBB without however, the typical stimulation pattern documented echocardiographically.
Identification criteria of LBBB typical mechanical stimulation in 2DSE are :1) early shortening of at least 1 basal or mid-ventricular segment in the septal wall and early stretching in at least 1 basal or midventricular segment in the lateral wall, 2) early septal peak shortening (within the first 70% of the ejection phase), and 3) lateral wall peak shortening after aortic valve closure.
The absence of one of the three criteria categorizes the patient in the group of atypical LBBB stimulation pattern.
Along with the development of the newest non-invasive imaging methods using ultrasound, the calculation of myocardial work (Myocardial Work) as well as the calculation of GWW (Global Wasted Work), GCW (Global Constructive Work) and GWE (Global Work Efficiency) is possible and can be used as a way of assessing myocardial function, the response to administered treatment (e.g. resynchronization therapy) as well as in the search for patients with the most likely response to a possible treatment.
The purpose of the study is to investigate which patients are most likely to benefit from LBBP pacing. Classic biventricular pacing will be compared with LBB pacing in patients requiring resynchronization with LVEF < 35%. At the same time, the presence or not of a typical LBBB- pattern of mechanical stimulation will be evaluated - documented through 2DSE (Two-dimensional strain echocardiography). - The immediate improvement of GWE in patients with succeeded LBB pacing - as documented by measurements in the electrophysiological laboratory- will be compared to the group of patients with the classical method of biventricular pacing (BiVp) as well as the correlation of the presence of the sonographic pattern of LBBB stimulation compared to the group of patients who do not present this mechanical activation pattern in ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Bundle branch Pacing | Experimental | Device: Left bundle branch pacing leadImplantation of a left bundle branch lead via sheath, to perform left bundle branch pacing |
| Conventional Bi- Ventricular pacing | Active comparator | Device: CRT with the standard method through csConventional resynchronization therapy using a vein through coronary sinus |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years < 90 years
- Patients with a documented indication for resynchronization therapy [symptomatic patients despite optimal medication, HFrEF (EF<35%), LBBB QRS morphology]
- COMPLETE LBBB (LBBB defined as QRS>130msec, wide "notched or slurred" R wave in leads I, aVL, V5, V6 and occasional RS pattern in V5, V6, absence of Q waves in leads I, V5 and V6 but in lead aVL narrow Q wave may be present in the absence of myocardial pathology, R peak time >60ms in leads V5 and V6 but normal in leads V1, V2, V3 when small R's are discernible in precardial leads, ST and T usually opposite to QRS direction)
- Patients with ntraventricular septum diameter >8 mm
- Written informed consent
Key exclusion criteria (3 listed)
- Patients with RBBB or atypical LBBB QRS morphology
- Patients eligible for an upgrade procedure (already carring a PM or ICD)
- Patients with hypertrophic cardiomyopathy
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 leadUse of LBBp Vs the standard method of BiVp in resynchronization therapy | Device | Left Bundle branch Pacing |
| CRT with the standard method through csstandard CRT procedure | Device | Conventional Bi- Ventricular pacing |
Primary outcome
GWE IMPROVEMENT
Time frame: Comparison in the acute phase after implantation (first to second day after the implantation))
Echocardiographic dyssynchrony index change, as expressed with Global Left Ventricular Myocardial Work Efficiency (GWE) (%) Change of myocardial work after LBBP/CRT implantation (correlation before and after)* and comparison in four groups based on the method of resynchronization (LBBp and BiVP) and ultrasound findings: a) Echo pattern typical LBBB b) Echo pattern atypical LBBB
3 secondary outcomes
Successful LBB pacing
Time frame: first day after the procedure
Complications associated with pacemaker implantation
Time frame: first day after the procedure
Procedure and Fluroscopy time (min)
Time frame: first day after the procedure
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 Dec 2025.
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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?
A study testing Left bundle branch pacing lead and CRT with the standard method through cs in people with Heart Failure With Reduced Ejection Fraction (HFrEF), 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 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. 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?
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?
Contact Georgios Leventopoulos, MD, PhD (30 2613603281, levent2669@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GWE IMPROVEMENT (time frame: Comparison in the acute phase after implantation (first to second day after the implantation))). 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 Dec 2025.