Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy
Recruiting · NCT07492979 · Interventional (participants receive a specific treatment) · Lead sponsor: Rigshospitalet, Denmark
View the official record on ClinicalTrials.gov →Interventions studied
Conventional BiV-CRTHIS or LBBB -CRT
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
5 locations listed.
- Dept. of Cardiology, Aarhus University Hospital, Aarhus - Aarhus, Denmark
- Haukeland Universitetssykehus - Bergen, Norway
- Rigshospitalet, Copenhagen University Hospital - Copenhagen, Denmark
- Sahlgrenska University Hospital - Gothenburg, Sweden
- Dept of Cardiology, Meilahti Hospital, Helsinki - Helsinki, Finland