About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Left bundle branch pacing lead
DeviceUse of LBBp Vs the standard method of BiVp in resynchronization therapy
CRT with the standard method through cs
Devicestandard CRT procedure
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
Procedure and Fluroscopy time (min)
Total procedure and fluroscopy time
Sponsors and contacts
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University Hospital of Patras
Lead sponsor
University General Hospital of Heraklion
Collaborator
Ippokrateio General Hospital of Thessaloniki
Collaborator
Onassis Cardiac Surgery Centre
Collaborator
Alexandra Hospital, Athens, Greece
Collaborator
Korgialenio-Benakio Red Cross Hospital
Collaborator
Ippokration General Hospital
Collaborator