UHF ECG in LBBB and Response to CRT Prediction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFaculty Hospital Kralovske Vinohrady

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HF due to ischemic or non-ischemic cardiomyopathy

known coronary angiography

NYHA II-IV

LVEF ≤40%

Disqualifiers

Age ˂18 years

heart failure from reversible causes

Moderate to severe aortic stenosis

pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • LBBAP CRT device implantation

    Device

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

  • BVP-CRT

    Device

    Implantation of biventricular device

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: CSP-CRT armExperimental treatment 1 intervention
Group B: BVP-CRT armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Left ventricular end-systolic volume

Left ventricular end-systolic volume reduction

Time frame
6 and 18 months since randomization

Secondary outcomes

Other outcomes

Sponsors and contacts

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