System Maintenance Notice

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Studies

Interventional Recruiting

NCT07279870 on ClinicalTrials.gov

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

Official title: RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease: the ITALIA Study

  • Sponsor: Policlinico S.Orsola-Malpighi
  • Enrollment: 1260 (Estimated)
  • Study start: 2025-12-03 (Actual)
  • Primary completion: 2030-12-31 (Estimated)
  • Study completion: 2031-06-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Atrioventricular Block

Intervention / Treatment

  • Procedure: Conduction System Pacing (CSP)
  • Procedure: Right Ventricular (RV) Pacing

Primary Outcome Measures

  • Heart failure (36 months after the PM implant)
    composite endponit of: number of HF events, HF hospitalizations and HF non-pharmacological interventions

Countries

Italy

Locations and Investigators

  • Azienda Ospedal iera "Card. G. Panico", Bari, Italy (Not yet recruiting)
    • Pietro Palmisano, MD
  • IRCCS AOUBO Policlinico di Sant'orsola, Bologna, Italy (Recruiting)
    • Mauro Biffi, MD
    • Susanna Maltoni
  • Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico -San Marco", Catania, Italy (Not yet recruiting)
    • Angelo Antonio Di Grazia
  • Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy (Recruiting)
  • ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy (Not yet recruiting)
    • Matteo Baroni, MD
  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara, Italy (Not yet recruiting)
    • Gabriele Dell'Era
  • Azienda Sanitaria locali di Asti Ospedale Cardinal Massaia, Novara, Italy (Not yet recruiting)
    • Marco Scaglione, MD
  • Azienda Ospedaliero-Univeritaria di Palermo - Policlinico Giaccone, Palermo, Italy (Not yet recruiting)
    • Giuseppe Coppola, MD
  • Azienda Ospedaliero-Universitaria di Parma, Parma, Italy (Not yet recruiting)
    • Maria Francesca Notarangelo, MD
  • Azienda Ospedaliera Santa Maria della Misericordia, Perugia, Italy (Not yet recruiting)
    • Gianluca Zingarini, MD
  • Policlinico Casilino, Roma, Italy (Not yet recruiting)
    • Leonardo Calò, MD
  • Ospedale di Rovigo Aulss 5 Polesana, Rovigo, Italy (Not yet recruiting)
    • Francesco Zanon, MD
  • Città delle Salute e della Scienza di Torino. Dipartimento Cardiovascolare e Toracico, Torino, Italy (Not yet recruiting)
    • Davide Castagno, MD
  • APSS Trento - Ospedale S. Maria del Carmine di Rovereto, Trento, Italy (Not yet recruiting)
    • Maurizio Del Greco, MD

Study Officials

  • Mauro Biffi, MD (Principal Investigator) — IRCCS AOUBO Policlinico di Sant'Orsola