Investigating heart function improvement in patients with specific heart pacing methods
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
This study tests whether a new heart pacing method can help people with heart failure feel better compared to the standard pacing method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital of Patras Academic / other |
| Locations | 1 site (Pátrai, Greece) |
| Trial ID | NCT06689111 on ClinicalTrials.gov |
What this trial studies
This multicenter interventional study aims to assess the relationship between a specific echocardiographic contraction pattern and the acute improvement in myocardial function in patients receiving cardiac resynchronization therapy. It focuses on patients with heart failure and reduced ejection fraction who require an implantable device. The study compares outcomes between those receiving left bundle branch pacing and conventional biventricular pacing, utilizing advanced echocardiographic techniques to evaluate heart function. The goal is to identify which patients are most likely to benefit from these therapies based on their echocardiographic patterns.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with symptomatic heart failure and a documented indication for resynchronization therapy.
Not a fit: Patients with right bundle branch block or atypical LBBB QRS morphology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for cardiac resynchronization therapy, enhancing treatment outcomes for heart failure patients.
How similar studies have performed: Other studies have shown promising results using echocardiographic patterns to predict responses to cardiac resynchronization therapy, indicating this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>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 Criteria: * Patients with RBBB or atypical LBBB QRS morphology * Patients eligible for an upgrade procedure (already carring a PM or ICD) * Patients with hypertrophic cardiomyopathy
Where this trial is running
Pátrai, Greece
- University Hospital of Patras — Pátrai, Greece, Greece (Recruiting)
Study contacts
- Study coordinator: Georgios Leventopoulos, MD, PhD
- Email: levent2669@hotmail.com
- Phone: 30 2613603281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.