UHF ECG in LBBB and Response to CRT Prediction

NCT07057544 | Recruiting

• 2 other identifiers: UHFBLOCK trialNW24-02-00143
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Left ventricular end-systolic volume

  Left ventricular end-systolic volume reduction

  6 and 18 months since randomization

Study Arms (2)

CSP-CRT arm

EXPERIMENTAL

In this arm, LBBAP CRT will be performed

Device: LBBAP CRT device implantation

BVP-CRT arm

ACTIVE COMPARATOR

In this arm, BVP CRT will be performed.

Device: BVP-CRT

Interventions

LBBAP CRT device implantation DEVICE

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

CSP-CRT arm

BVP-CRT DEVICE

Implantation of biventricular device

BVP-CRT arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, Česká Republika, 10034, Czechia

RECRUITING

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Karol Curila, MD

CONTACT

+420777869171; karol.curila@fnkv.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CZ (1)