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Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy

ConditionsCardiac Resynchronisation Therapy (CRT)Heart FailureConduction System Pacing
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HIS or LBBB -CRT

    Procedure/Surgery

    HIs pacing og LBB pacing at the implanteres discretion

  • Conventional BiV-CRT

    Procedure/Surgery

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

Treatment groups

1,100 Participants
are divided into 2 treatment groups
Group A: LBB/HIS-CRT groupExperimental treatment 1 intervention
Group B: BiV-CRT groupExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Patients experiencing device-related complications

• Device-related complications. Periprocedural complication including electrode reoperation, pneumothorax, hemothorax, pericardial bleeding/tamponade and later complications (after 30 days post implantation) including LV/His electrode reoperation, change of device due to battery depletion and infection requiring extraction.

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

Death

All-cause death

Time frame
From baseline until study completion, with a minimum of 2 years
3

Non planned HF-hospitalization

Non-planned HF is defined as an unplanned emergency room visit or admission to hospital due to worsening HF

Time frame
From baseline until study completion with a minimum of 2 years
4

Echocardiographic remodelling

Echocardiographic end-points (re-modelling of the LV measured in mL: LVESV, LVEDV, LVEF). Echocardiographic response after 6 months and 24 months defined as decrease in left ventricular systolic volume ≥ 15% from baseline.

Time frame
From baseline to 6 months and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Source ClinicalTrials.gov
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