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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?

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• ≥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.

Locations
Other Locations
Denmark
Dept. of Cardiology, Aarhus University Hospital, Aarhus
NOT_YET_RECRUITING
Aarhus
Rigshospitalet, Copenhagen University Hospital
RECRUITING
Copenhagen
Finland
Dept of Cardiology, Meilahti Hospital, Helsinki
NOT_YET_RECRUITING
Helsinki
Norway
Haukeland Universitetssykehus
NOT_YET_RECRUITING
Bergen
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Contact Information
Primary
Niels Risum, MD, PhD
niels.risum.01@regionh.dk
0045 35456995
Backup
Michael Vinther, MD, PhD
michael.vinther@regionh.dk
0045 35456994
Time Frame
Start Date: 2026-06-17
Estimated Completion Date: 2031-07-01
Participants
Target number of participants: 1100
Treatments
Experimental: LBB/HIS-CRT group
Experimental: BiV-CRT group
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov

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