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 groupsLocations
4Denmark
Dept. of Cardiology, Aarhus University Hospital, Aarhus8200, Aarhus Denmark
Finland
Dept of Cardiology, Meilahti Hospital, Helsinki00290, Helsinki Finland
Norway
Haukeland Universitetssykehus5009, Bergen Norway
Sweden
Sahlgrenska University Hospital Gothenburg Sweden
Sponsors and collaborators
Rigshospitalet, Denmark
Lead sponsor
Source ClinicalTrials.gov