Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy

NCT07492979 | Not Yet Recruiting DMC

• 1 other identifier: 119231
• Study Type: interventional
• Target: 1,100
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Cardiac Resynchronisation Therapy (CRT); Heart Failure; Conduction System Pacing

Keywords

Nordic-CSP; conduction system pacing; His-pacing; LBB-pacing; Biventricular pacing; Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

• Patients with a primary end-point

  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

  From enrollment and a minimum of 2 years or the primary outcome has occurred

Secondary Outcomes (17)

• Patients experiencing device-related complications

  From baseline until study completion, with a minimum of 2 years.

• Death

  From baseline until study completion, with a minimum of 2 years

• Non planned HF-hospitalization

  From baseline until study completion with a minimum of 2 years

• Echocardiographic remodelling

  From baseline to 6 months and 24 months

• Change in Dyssynchrony

  evaluated at baseline, 6 months, 24 months

Study Arms (2)

LBB/HIS-CRT group

EXPERIMENTAL

Procedure: HIS or LBBB -CRT

BiV-CRT group

EXPERIMENTAL

Procedure: Conventional BiV-CRT

Interventions

HIS or LBBB -CRT PROCEDURE

HIs pacing og LBB pacing at the implanteres discretion

LBB/HIS-CRT group

Conventional BiV-CRT PROCEDURE

An LV-lead in a side-branch of the coronary sinus

BiV-CRT group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (4)

Dept. of Cardiology, Aarhus University Hospital, Aarhus

Aarhus, 8200, Denmark

Location

Dept of Cardiology, Meilahti Hospital, Helsinki

Helsinki, 00290, Finland

Location

Haukeland Universitetssykehus

Bergen, 5009, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Niels Risum Risum, MD, PhD

  Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• michael vinther, MD, PhD

  Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Berit Philbert

  Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

  STUDY CHAIR

Central Study Contacts

Niels Risum, MD, PhD

CONTACT

0045 35456995; niels.risum.01@regionh.dk

Michael Vinther, MD, PhD

CONTACT

0045 35456994; michael.vinther@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD, Consultant cardiologist and electrophsiologist,

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); NO (1); DK (1); SE (1)