Conduction system pacing vs. traditional pacing in adults with atrioventricular block

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 randomized, interventional trial compares conduction system pacing with conventional right ventricular pacing in about 1,260 adults undergoing pacemaker implantation for AV conduction disease. It aims to see if the new pacing approach reduces cardiac decompensation, improves quality of life, and is cost-effective in clinical practice. The study will assess outcomes in patients with AV block in sinus rhythm or atrial tachyarrhythmias, including those undergoing AV node ablation with ventricular stimulation. Participants will be followed to evaluate feasibility, safety, and potential impact on health status and economic impact.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients with AV block in either sinus rhythm (SR) or permanent atrial tachycardia/atrial fibrillation (AT/AF), or with slow AV conduction during AT/AF, or undergoing AV node ablation + ventricular stimulation
* male and female
* acquired informed consent

Exclusion Criteria:

* Class I indication to Implantable Cardioverter Defibrillator (ICD) or to Cardiac Resynchronization Therapy (CRT)
* Ejection Fraction \< 35%
* Life expectancy \< 2 years
* Participation in another clinical trial which might impact on the study outcome
* Pregnancy, except as "In the event of an ongoing pregnancy, the doctor and patient will jointly assess, on a case-by-case basis and in the best interests of the patient, whether to propose participation in the study (random assignment to one of the two stimulation techniques) or to proceed as per clinical practice (assignment to one of the two stimulation techniques by the doctor). A screening log file of all eligible patients will be recorded, detailing the reason/s for non-randomization."

Where it's running

• IRCCS AOUBO Policlinico di Sant'orsola
  Bologna, Italy Recruiting
• Azienda Ospedaliero-Universitaria di Ferrara
  Ferrara, Italy Recruiting
• Azienda Ospedal iera "Card. G. Panico"
  Bari, Italy Not yet recruiting
• Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"
  Catania, Italy Not yet recruiting
• ASST Grande Ospedale Metropolitano Niguarda
  Milan, Italy Not yet recruiting
• Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
  Novara, Italy Not yet recruiting

Study contacts

• Principal investigator: Mauro Biffi, MD — IRCCS AOUBO Policlinico di Sant'Orsola
• Study coordinator: Mauro Biffi, MD
• Email: mauro.biffi@aosp.bo.it
• Phone: +390512149034

Similar studies

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

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• Left bundle area pacing with Closed Loop Stimulation in dual‑chamber pacemakers

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• Remote ECG monitoring after TAVI

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• Comparing two pacemaker pacing methods for AV block

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• Left bundle branch pacing versus right ventricular pacing to reduce device‑detected fast atrial episodes in people with preserved ejection fraction

  This trial will test whether left bundle branch pacing (LBBP) reduces the total time people with preserved ejection fraction spend in device‑detected fast atrial episodes compared with standard right ventricular pacing.

  Recruiting University Hospital of Patras · Pátrai · NCT07250529

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.