Conduction system pacing vs biventricular pacing for CRT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Nordic randomized trial compares conduction system pacing (HIS-pacing or left bundle branch pacing) to conventional biventricular CRT in adults with heart failure and reduced ejection fraction. It is blinded for endpoint adjudicators and imaging personnel, with randomization occurring at the time of device implantation and stratified by bundle branch block type and RV pacing. The primary goal is to reduce the composite of death and non-planned heart failure hospitalization. Enrollment spans multiple centers in Denmark, Sweden, Norway, and Finland, with follow-up designed to be equivalent between arms. The study is investigator-initiated and aims to clarify whether CSP can improve outcomes for CRT patients at risk of poor prognosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥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.

Exclusion Criteria:

* 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.

Where it's running

• Rigshospitalet, Copenhagen University Hospital
  Copenhagen, Denmark Recruiting
• Dept. of Cardiology, Aarhus University Hospital, Aarhus
  Aarhus, Denmark Not yet recruiting
• Dept of Cardiology, Meilahti Hospital, Helsinki
  Helsinki, Finland Not yet recruiting
• Haukeland Universitetssykehus
  Bergen, Norway Not yet recruiting
• Sahlgrenska University Hospital
  Gothenburg, Sweden Not yet recruiting

Study contacts

• Principal investigator: Niels Risum Risum, MD, PhD — Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
• Study coordinator: Niels Risum, MD, PhD
• Email: niels.risum.01@regionh.dk
• Phone: 0045 35456995

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pacing decisions guided by risk for pacing-induced heart muscle weakness

  This study tests a risk score to predict pacing-induced cardiomyopathy in adults getting heart rhythm devices, to tailor pacing choices.

  Recruiting at 2 sites Insel Gruppe AG, University Hospital Bern · Canberra, Australian Capital Territory and 12 other locations · NCT07276139

• Left bundle branch area pacing with Tendril STS or UltiPace leads

  This study will try left bundle branch area pacing with the Tendril STS or UltiPace lead in adults who need pacemaker leads for bradycardia or related heart conditions to see if pacing and sensing are safe and work through six months after implant.

  Recruiting at 13 sites Abbott Medical Devices · Rio de Janeiro, Rio de Janeiro and 14 other locations · NCT07217392

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Comparing two pacing methods for heart failure patients

  This study is testing whether a new pacing method called conduction system pacing can help heart failure patients just as much as the standard biventricular pacing to improve their heart function.

  Recruiting The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06241651

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

• Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS

  Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07912086

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.