Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorRigshospitalet, Denmark
About this trial
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 criteria
Qualifiers
≥18 years of age,
LVEF ≤ 35%,
NYHA Class II-IV (IV only outpatients),
optimized in medical treatment (OMT)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HIS or LBBB -CRT
- Conventional BiV-CRT
Treatment groups
1,100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov