An interventional study of Left bundle branch pacing lead and CRT with the standard method through cs in Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by University Hospital of Patras. Recruiting at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by University Hospital of Patras · Not applicable, Interventional, and Treatment
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)
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 100 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University Hospital of Patras is the lead sponsor of 43 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implantation of a left bundle branch lead via sheath, to perform left bundle branch pacing
Device: Left bundle branch pacing lead
Conventional resynchronization therapy using a vein through coronary sinus
Device: CRT with the standard method through cs
Use of LBBp Vs the standard method of BiVp in resynchronization therapy
standard CRT procedure
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
Time frame: Comparison in the acute phase after implantation (first to second day after the implantation))
Successful LBB pacing
These include the presentation of R' in V1 and at least on of the following: 1. Threshold test: the transition from nonselective LBBP (NS-LBBP) to S-LBBP 2. V6RWPT\< 80ms 3. V6-V1 inter-peak interval \>44ms 4. Potential- V6RWPT =stim-V6RWPT (+/-10ms) 5. QRS transition ns - LBBB to s-LBBB by programmed stimulation S1S2
Time frame: 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
Time frame: first day after the procedure
Procedure and Fluroscopy time (min)
Total procedure and fluroscopy time
Time frame: first day after the procedure
Started May 2024 (actual). Primary completion is estimated for Sep 2026, 28 months after the start.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 28 months is close to that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
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University Hospital of Patras