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Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy

RECRUITINGN/ASponsored by Rigshospitalet, Denmark
Actively Recruiting
PhaseN/A
SponsorRigshospitalet, Denmark
Started2026-06-17
Est. completion2031-03-01
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted

Summary

The NORDIC-CSP trial is an investigator-initiated, blinded, nordic RCT aimed at evaluating whether using direct pacing of the HIS bundle (HIS)-pacing or left bundle branch (LBB) pacing is superior to conventional biventricular pacing in reducing the incidence of the composite endpoint of death and non-planned HF hospitalization. The study will be conducted in the 4 CRT-centres in Denmark and 6-8 centres from countries Sweden, Norway and Finland.

Eligibility

Age: 18 Years – 99 YearsHealthy volunteers accepted
Inclusion Criteria:

* ≥18 years of age,
* LVEF ≤ 35%,
* NYHA Class II-IV (IV only outpatients),
* optimized in medical treatment (OMT)

AND one of the following:

. LBBB according to AHA/ACC/HRS Scientific Statement from 2009 and ≥130ms or

* LBBB-like intraventricular conduction delay (IVCD) \> 150ms or RV paced QRS and indication for upgrade to CRT (\> 40% RV pacing) OR
* ≥18 years of age,
* LVEF ≤ 40 %
* pacing indicated by AV-block and, thus, expected large percentage of ventricular pacing.

Exclusion Criteria:

* recent acute myocardial infarction (AMI)
* coronary artery bypass graft (CABG) (\<3 months)
* life expectancy \<2 years, patients in hemodialysis
* treatment with a cardiac implantable electronic device (CIED) is contraindicated.
* Patients are excluded with regards to the MRI sub study if eGFR \> 35 ml/min, in case or contrast allergy or certain metal implants.

Conditions4

Cardiac Resynchronisation Therapy (CRT)Conduction System PacingHeart DiseaseHeart Failure

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