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RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease

RecruitingNAAges 18 Years - anyAllIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT07279870 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Study objective is to assess whether stimulation of the conduction system reduces cardiac decompensation events in patient follow-up, and how applicable this is in clinical practice and also to determine the impact of the studied interventions in terms of quality of life and cost-effectiveness for the treatment of patients with atrioventricular block. 1260 adult patients who are candidates for pacemaker implantation for the treatment of atrioventricular conduction disease will be randomised to stimulation of the conduction system or to the conventional stimulation.

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📋 Eligibility rules (as published)
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."
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What it tests

  • Conduction System Pacing (CSP)
  • Right Ventricular (RV) Pacing
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Where

14 sites
Azienda Ospedal iera "Card. G. Panico"
Bari, Italy
IRCCS AOUBO Policlinico di Sant'orsola
Bologna, Italy
Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco"
Catania, Italy
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy
Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia
Novara, Italy
Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone
Palermo, Italy

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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