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Search / Trial NCT05467163

Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation

Launched by UNIVERSITY MEDICAL CENTRE LJUBLJANA · Jul 17, 2022

Trial Information

Current as of November 13, 2025

Recruiting

Keywords

Heart Failure Atrial Fibrillation Conduction System Pacing His Bundle Pacing Left Bundle Branch Pacing Biventricular Pacing Atrioventricular Node Ablation

ClinConnect Summary

This clinical trial is studying two different types of pacing methods for patients with heart failure and atrial fibrillation, a condition where the heart beats irregularly. The researchers want to compare conduction system pacing (CSP), which may help the heart work more naturally, with biventricular pacing (BiV), a more traditional method. Both methods will be tested on patients who are scheduled to undergo a procedure called atrioventricular node ablation (AVNA), which is meant to control their heart rhythm. The goal is to see if CSP provides similar or better outcomes than BiV pacing.

To join this study, participants must be between 18 and 85 years old, have a specific type of atrial fibrillation that hasn’t responded well to medications or other treatments, and have a weakened heart (with a left ventricular ejection fraction less than 50%). They should not have certain heart devices already in place and must be able to give their consent to participate. Those who enroll will be monitored closely to see how well each pacing method works for their heart condition. This trial is currently recruiting participants, and it offers an opportunity to help improve treatment options for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Symptomatic permanent atrial fibrillation, refractory to drug therapy or failed catheter ablation
  • 2. Left ventricular ejection fraction \<50%
  • 3. Narrow intrinsic QRS ≤ 120 ms
  • 4. NT-proBNP \> 600 ng/L
  • 5. Patient has provided written informed consent
  • 6. Age between 18 years and 85 years
  • Exclusion Criteria:
  • 1. Pre-existing permanent pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization device. Patients who had devices implanted that had \<5% of paced beats (i.e., backup pacing) can be enrolled.
  • 2. Life expectancy less than 12 months
  • 3. Severe concomitant non-cardiac disease
  • 4. Pregnancy
  • 5. Recent (\<3 months) myocardial infarction, percutaneous or surgical myocardial revascularization
  • 6. Significant heart valve disease (severe insufficiency or stenosis)
  • 7. Contraindication for oral anticoagulation
  • 8. Mechanical tricuspid valve replacement
  • 9. Unwillingness to participate or lack of availability for follow-up

About University Medical Centre Ljubljana

University Medical Centre Ljubljana (UMCL) is a leading academic medical institution in Slovenia, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMCL integrates cutting-edge medical practices with comprehensive patient care, fostering an environment of collaboration among healthcare professionals, researchers, and patients. With a strong emphasis on ethical standards and scientific integrity, UMCL aims to contribute to the global body of medical knowledge while improving treatment outcomes in various therapeutic areas.

Locations

Zagreb, Croatia

Rijeka, Croatia

Split, Croatia

Ljubljana, Slovenia

Graz, Austria

Sofia, Bulgaria

Rijeka, Croatia

Braşov, Romania

Ljubljana, Slovenia

Genk, Belgium

Graz, Austria

Sofia, Bulgaria

Sofia, Bulgaria

Braşov, Romania

Budapest, Hungary

Patients applied

0 patients applied

Trial Officials

Andrej Pernat, MD, PhD

Study Director

UMC Ljubljana

David Zizek, MD, PhD

Principal Investigator

UMC Ljubljana

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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