REstoration of SYNChronous Cardiac Function Due to Physiologic cArdiac Pacing Modalities With Clinical Endpoints

Starting soon

Conditions studied: Heart Failure - NYHA II - IV, Left Bundle Branch Area Pacing, Left Bundle Branch Block, Intraventricular Conduction Delay, Resynchronization Therapy

In brief

The goal of this observational study is to evaluate the long-term clinical outcomes of physiologic cardiac resynchronization therapy (CRT) using conduction system pacing strategies compared with conventional biventricular CRT in patients with heart failure with reduced ejection fraction (HFrEF) and electrical dyssynchrony. The main questions it aims to answer are: * Does physiologic CRT (including left bundle branch area pacing \[LBBAP\] and LBBAP-optimized CRT) reduce the combined risk of all-cause mortality and heart failure hospitalization compared with conventional biventricular CRT? * Does physiologic CRT improve cardiac function and reverse ventricular remodeling more effectively than conventional CRT? Participants receiving physiologic CRT as part of routine clinical care will undergo standard follow-up evaluations, including electrocardiography, echocardiography, laboratory testing, and device interrogation. Clinical outcomes will be collected prospectively for 24 months and compared with a historical cohort of patients treated with conventional biventricular CRT. The study will assess clinical outcomes, echocardiographic response, electrical resynchronization parameters, and device-related safety in a real-world heart failure population.

Key facts

Study ID

NCT07684547

Run by

University of Pecs

People needed

50

Starts

2026-06-29

Expected to finish

2031-06-29

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years.
• Symptomatic heart failure despite guideline-directed medical therapy.
• Left ventricular ejection fraction (LVEF) ≤40%.
• Indication for cardiac resynchronization therapy according to contemporary ESC guideline recommendations.
• QRS duration ≥150 ms with either:
• Left bundle branch block (LBBB), or Intraventricular conduction delay (IVCD).
• Planned implantation of a CRT system
• Ability to provide written informed consent
• Expected survival greater than 24 months.

You may not qualify if…

• Age <18 years and Age 100 < years
• Pregnancy or breastfeeding.
• Inability or unwillingness to provide informed consent.
• Life expectancy <12 months due to non-cardiac comorbidities.
• Active systemic infection or infection involving a cardiac implantable electronic device.
• Reversible causes of heart failure expected to improve without CRT.
• Participation in another interventional clinical trial that may affect study outcomes.
• Inability to comply with follow-up requirements.
• Missing essential baseline or follow-up data (retrospective cohort).
• Any condition that, in the opinion of the investigators, would make participation inappropriate or interfere with study assessments.

Where it is running

• Heart Institute , University of Pécs — Pécs, Baranya, Hungary

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.