RecruitingNot ApplicableNCT07057544

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


Sponsor

Faculty Hospital Kralovske Vinohrady

Enrollment

200 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria12

  • 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

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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


Locations(1)

Faculty Hospital Kralovske Vinohrady

Prague, Česká Republika, Czechia

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NCT07057544


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