RecruitingNot ApplicableNCT06689111

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)

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


Sponsor

University Hospital of Patras

Enrollment

100 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria5

  • \>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

Exclusion Criteria3

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

Interventions

DEVICELeft bundle branch pacing lead

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

DEVICECRT with the standard method through cs

standard CRT procedure


Locations(1)

University Hospital of Patras

Pátrai, Greece, Greece

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06689111


Related Trials