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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Hospital of Patras

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 volunteers

Qualifiers

>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

Design model

Parallel

Treatments tested in this trial

  • Left bundle branch pacing lead

    Device

    Use of LBBp Vs the standard method of BiVp in resynchronization therapy

  • CRT with the standard method through cs

    Device

    standard CRT procedure

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Left Bundle branch PacingExperimental treatment 1 intervention
Group B: Conventional Bi- Ventricular pacingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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))

Secondary outcomes

1

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
2

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
3

Procedure and Fluroscopy time (min)

Total procedure and fluroscopy time

Time frame
first day after the procedure

Other outcomes

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