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)

NCT06689111 | Recruiting DMC FDA Device

• 1 other identifier: 337/23.05.2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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)

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Outcome Measures

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

  Comparison in the acute phase after implantation (first to second day after the implantation))

Secondary Outcomes (3)

• Successful LBB pacing

  first day after the procedure

• Complications associated with pacemaker implantation

  first day after the procedure

• Procedure and Fluroscopy time (min)

  first day after the procedure

Study Arms (2)

Left Bundle branch Pacing

EXPERIMENTAL

Implantation of a left bundle branch lead via sheath, to perform left bundle branch pacing

Device: Left bundle branch pacing lead

Conventional Bi- Ventricular pacing

ACTIVE COMPARATOR

Conventional resynchronization therapy using a vein through coronary sinus

Device: CRT with the standard method through cs

Interventions

Left bundle branch pacing lead DEVICE

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

Left Bundle branch Pacing

CRT with the standard method through cs DEVICE

standard CRT procedure

Conventional Bi- Ventricular pacing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• Patients with RBBB or atypical LBBB QRS morphology
• Patients eligible for an upgrade procedure (already carring a PM or ICD)
• Patients with hypertrophic cardiomyopathy

Sponsors & Collaborators

• University Hospital of Patras: lead
• University General Hospital of Heraklion: collaborator
• Onassis Cardiac Surgery Centre: collaborator
• Korgialenio-Benakio Red Cross Hospital: collaborator
• Ippokration General Hospital: collaborator
• Ippokrateio General Hospital of Thessaloniki: collaborator
• Alexandra Hospital, Athens, Greece: collaborator

Study Sites (1)

University Hospital of Patras

Pátrai, Greece, 26504, Greece

RECRUITING

Central Study Contacts

Georgios Leventopoulos, MD, PhD

CONTACT

30 2613603281; levent2669@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 14, 2024
• Study Start: May 23, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

GR (1)