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Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy

ConditionsCardiac Resynchronisation Therapy (CRT)Heart FailureConduction System Pacing
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

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

This trial is not recruiting at the moment. You can still explore other options: