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UHF ECG in LBBB and Response to CRT Prediction

The Role of Ultra-high-frequency ECG in the Localization of Left Ventricular Conduction Disorders and Prediction of Response to Resynchronization Therapy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07057544
Acronym
UHF BLOCK
Enrollment
200
Registered
2025-07-10
Start date
2024-05-01
Completion date
2027-12-31
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biventricular Pacing, Intraventricular Conduction Delay, Left Bundle Branch Area Pacing, Left Bundle Branch Block

Keywords

left bundle branch block, resynchronization therapy, intraventricular conduction delay, left bundle branch pacing, biventricular pacing

Brief summary

The main objective of the project is to demonstrate that in patients with heart failure and QRS complex of nonRBBB morphology lasting over 130 ms, UHF-ECG can differentiate patients with trueLBBB from IVCD better than existing approaches based on the assessment of QRS complex morphology and duration from 12-lead ECG. Another goal of the proposed study is to demonstrate that trueLBBB patients will benefit more from CRT using left bundle branch pacing than from CRT using biventricular pacing. The final aim of the project is to demonstrate that the echocardiographic and clinical response in patients with intraventricular conduction disturbance will be dependent on the degree of reduction in ventricular dyssynchrony after CRT.

Detailed description

Since the introduction of cardiac resynchronization therapy (CRT), a way to better define the patients who will benefit from it most has been sought. Their selection based on the duration of the QRS complex or its morphology fails in some of them. Current data demonstrate that CRT done by pacing the conduction system below the site of the left bundle branch block may be a better therapy than biventricular pacing. A prerequisite for a better effect of conduction system pacing is to perform it in patients in whom a conduction block is present in the left bundle branch block (true LBBB) and not in the patients with a more distal left ventricular conduction problem (IVCD). The criteria derived from the surface standard ECG are insufficient to differentiate true LBBB from IVCD, and thus it is not possible to determine the optimal treatment in some patients. The sequence of ventricular activation can be visualized within a few minutes using ultra-highfrequency ECG (UHF-ECG) in virtually all patients. It is a non-invasive method that shows ventricular dyssynchrony as a time difference between the activation of the ventricles or their individual segments. Pilot data show that patients with true LBBB are likely to have greater ventricular dyssynchrony and a different pattern of ventricular depolarization than patients with IVCD. The aim of this project is to test the hypothesis that UHF-ECG can distinguish true LBBB from IVCD in patients with heart failure and left ventricular conduction disturbance better than using standard criteria assessing QRS duration and morphology. Other aim is to demonstrate that in patients with trueLBBB resynchronization using conduction system pacing will lead to better echocardiographic and clinical outcomes than biventricular pacing. Finally, the echocardiographic and clinical response of IVCD patients will depend on the reduction of UHF-ECG ventricular dyssynchrony after CRT.

Interventions

DEVICELBBAP CRT device implantation

Pacing system with a lead implanted in the left bundle branch area will be done.

DEVICEBVP-CRT

Implantation of biventricular device

Sponsors

Faculty Hospital Kralovske Vinohrady
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HF due to ischemic or non-ischemic cardiomyopathy * known coronary angiography * NYHA II-IV * LVEF ≤40% * non-RBBB QRSd lasting \>130 ms (by automated measurement) * proximal LBBB proved by an invasive EP study or non-invasive dyssynchrony assessment in case such a method is confirmed to be non-inferior to an invasive EP study during the project

Exclusion criteria

* Age ˂18 years * heart failure from reversible causes * Moderate to severe aortic stenosis * pregnancy * active myocarditis * hypertrophic cardiomyopathy * cardiac valve surgery in the last three months * myocardial infarction, PCI, or CABG in the last three months * severe valvular disease requiring intervention * severe atherosclerotic disease of the aorta and/or femoral arteries * life expectancy ˂1 year * known medical condition or contraindication causing potential complications for EP study

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular end-systolic volume6 and 18 months since randomizationLeft ventricular end-systolic volume reduction

Countries

Czechia

Contacts

Primary ContactKarol Curila, MD
karol.curila@fnkv.cz+420777869171

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026