Cardiac Resynchronisation Therapy (CRT)Heart FailureConduction System Pacing
Investigational drug(s) / intervention(s)
HIS or LBBB -CRTConventional BiV-CRT
HIS or LBBB -CRT: HIs pacing og LBB pacing at the implanteres discretion
Conventional BiV-CRT: An LV-lead in a side-branch of the coronary sinus
Study 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
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Patients with a primary end-point — From enrollment and a minimum of 2 years or the primary outcome has occurred The primary endpoint is a composite of time to death or first non-planned HF hospitalization. Non-planned HF is defined as an unplanned emergency room visit or admission to hospital due to worsening HF
Trial sites (5)
Facility
City
Region
Status
Dept. of Cardiology, Aarhus University Hospital, Aarhus
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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