Clinical Trial Radar

Name: Nordic-CSP - a Randomized Nordic Study - Is Conduction System Pacing Superior Compared to Conventional BIV-CRT in Reducing the Death or Heart Failure-related Hospitalization in Patients With Heart Failure and Bundle Branch Block?
Creator: Rigshospitalet, Denmark
Published: 2026-03-25
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

beta

Trial Radar AI Trial Candidate or Patient Patient Caregiver Healthcare Pro Biotech Pro Biotech Investor Researcher Other
	Clinical Trial NCT07492979 (Nordic-CSP) for Cardiac Resynchronisation Therapy (CRT), Heart Failure, Conduction System Pacing is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

One study matched filter criteria

Card View

Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy (Nordic-CSP) 1,100 Investigator-Initiated

Not yet recruiting

Clinical Trial NCT07492979 (Nordic-CSP) is an interventional study for Cardiac Resynchronisation Therapy (CRT), Heart Failure, Conduction System Pacing and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2026 and continue until the study accrues 1,100 participants. Led by Rigshospitalet, Denmark, this study is expected to complete by 1 July 2031. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.

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 countrie...Show More

Detailed Description

In this investigator-initiated, blinded, nordic RCT, we will investigate conduction system pacing (CSP) in heart failure (HF) patients. We hypothesized that Cardiac Resynchronization Therapy (CRT) by HIS-pacing or LBB-pacing is superior compared to conventional biventricular (BIV)-CRT in reducing the incidence of the composite endpoint (Death and HF-hospitalization) in patients with symptomatic HF, with LVEF ≤ 35% an...Show More

Official Title

Nordic-CSP - a Randomized Nordic Study - Is Conduction System Pacing Superior Compared to Conventional BIV-CRT in Reducing the Death or Heart Failure-related Hospitalization in Patients With Heart Failure and Bundle Branch Block?

Conditions

Cardiac Resynchronisation Therapy (CRT)Heart FailureConduction System Pacing

Other Study IDs

Nordic-CSP
119231

NCT ID Number

NCT07492979

Start Date (Actual)

2026-03-01

Last Update Posted

2026-03-25

Completion Date (Estimated)

2031-07-01

Enrollment (Estimated)

1,100

Study Type

Interventional

PHASE

N/A

Status

Not yet recruiting

Keywords

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

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

Double

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalLBB/HIS-CRT group	HIS or LBBB -CRT HIs pacing og LBB pacing at the implanteres discretion
ExperimentalBiV-CRT group	Conventional BiV-CRT An LV-lead in a side-branch of the coronary sinus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline until study completion, with a minimum of 2 years.
Death	All-cause death	From baseline until study completion, with a minimum of 2 years
Non planned HF-hospitalization	Non-planned HF is defined as an unplanned emergency room visit or admission to hospital due to worsening HF	From baseline until study completion with a minimum of 2 years
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.	From baseline to 6 months and 24 months
Change in Dyssynchrony	Change in dyssynchrony parameters myocardial work, longitudinal strain time-to-peak (ms), dyssynchrony patterns (categorized 1-4), apical rocking, septal flash (yes/No)	evaluated at baseline, 6 months, 24 months
Improvement in Clinical response	Clinical response improvement in NYHA class by ≥ 1 or improvement in 6MWT (≥10% from baseline)" after 12 months.	from baseline to 12 months
Improvement in Six-min walking test.	Functional response after 6 months defined as an increase in 6-min walking distance (meters) of ≥ 20% of the baseline value	From baseline to 6 months
Neurohormones	Neurohormones, decline in NT-proBNP after CRT. pg/mL (picograms per milliliter) or ng/L (nanograms per liter)	from baseline to 6 months
Symptomatic response	defined as a fall in NYHA class of ≥ 1	From baseline to 6 months
Life quality	Minnesota Living with Heart Failure Qestionnaire. Comparison from baseline to 12 months follow-up in point score (0-105). Number of patients with improvements \> 5 points and above 10 points are determined.	from baseline to follow-up at 12 months
ICD therapy	ICD-therapy (time to first) of appropriate and inappropriate therapies, ATP or Shock	from baseline to study completion, with a mnimum of 2 years
Ventricular arrythmia	Time to first VT (\>135/min by ecg or device reading) or VF	from baseline to completion of the study, with a mnimum of 2 years
atrial fibrillation	time to Persistent atrial fibrillation (\> 7 days) and new-onset atrial fibrilllation (\> 6 hours)	from baseline to completion of the study with a minimum of 2 years
time for implantation	measured in minutes from skin incision to skin closure	at implantation, from 30 minutes to 300 minutes
x-ray	• Use of X-ray dosage	at implantation, from 1 minute to 150 minutes
Electrodes	number of electrodes used	form implantation to completion of the study, a minimum of 2 years
battery longevity	• Battery longevity: The total battery longevity of each CRT-D was calculated as the sum of the patient's follow-up duration plus the estimated battery longevity remaining at the time of the last follow-up.	from implantation to completion of the study, with a minimum of 2 years

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

≥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.

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.

Rigshospitalet, Denmark

Study Responsible Party

Niels Risum, Principal Investigator, Md, PhD, Consultant cardiologist and electrophsiologist,, Rigshospitalet, Denmark

Study Central Contact

Contact: Niels Risum, MD, PhD, 0045 35456995, [email protected]

Contact: Michael Vinther, MD, PhD, 0045 35456994, [email protected]

4 Study Locations in 4 Countries

Denmark

Dept. of Cardiology, Aarhus University Hospital, Aarhus, Aarhus, 8200, Denmark

Jens Kristensen, MD, PhD, Contact, 0045 29410644, [email protected]

Finland

Dept of Cardiology, Meilahti Hospital, Helsinki, Helsinki, 00290, Finland

Jarkko Karvonen Karvonen, Contact, [email protected]

Norway

Haukeland Universitetssykehus, Bergen, 5009, Norway

Torbjørn Lunde, Contact, 0047 xxxxxxxx, [email protected]

Sweden

Sahlgrenska University Hospital, Gothenburg, Sweden

Amar Taha, Contact, 0046 313427551, [email protected]

Conduction System Pacing vs. Biventricular Pacing for Cardiac Resynchronization Therapy (Nordic-CSP) 1,100 Investigator-Initiated

Inclusion Criteria

Exclusion Criteria