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TerminatedNo phase

Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease

Reason given: Stopping criterion met (N. adjudicated EP1)

Key facts

Where
Acquaviva delle Fonti, Bari, Campobasso, Casarano, Caserta, Catania, Conegliano, Eboli, Florence, Frosinone, Gallarate, Garbagnate, Isernia, Lecce, Massa, Naples, Novara, Orvieto, Padova, Perugia, Prato, Ragusa, Rho, Rimini, Roma, Rome, San Fermo della Battaglia, Savigliano, Seriate, Terni, Torrette, and Treviso, ItalySee the 34 sites

Where in Italy

  • Ospedale Generale Regionale " F.Miulli "Acquaviva delle Fonti, ItalyNo longer taking part
  • Azienda Ospedaliera Policlinico ConsorzialeBari, ItalyNo longer taking part
  • Ospedale Antonio CardarelliCampobasso, ItalyNo longer taking part
  • Ospedale F. FerrariCasarano, ItalyNo longer taking part
  • Azienda Ospedaliera di Caserta Sant'Anna e San SebastianoCaserta, ItalyNo longer taking part
  • A.O.U. Policlinico Vittorio EmanueleCatania, ItalyNo longer taking part
  • Ospedale di ConeglianoConegliano, ItalyNo longer taking part
  • Ospedale Maria SS AddolorataEboli, ItalyNo longer taking part
  • Ospedale Santa Maria NuovaFlorence, ItalyNo longer taking part
  • Ospedale Fabrizio SpazianiFrosinone, ItalyNo longer taking part
  • ASST Valle Olona - Ospedale Sant'Antonio AbateGallarate, ItalyNo longer taking part
  • ASST RHODENSE - Ospedale Guido SalviniGarbagnate, ItalyNo longer taking part
  • Ospedale Ferdinando VenezialeIsernia, ItalyNo longer taking part
  • Ospedale Vito FazziLecce, ItalyNo longer taking part
  • Nuovo Ospedale delle ApuaneMassa, ItalyNo longer taking part
  • A.O.P. Federico IINaples, ItalyNo longer taking part
  • Ospedale V. MonaldiNaples, ItalyNo longer taking part
  • A.O.U. Maggiore della Carità di NovaraNovara, ItalyNo longer taking part
  • Ospedale Santa Maria della StellaOrvieto, ItalyNo longer taking part
  • Azienda Ospedaliera di PadovaPadova, ItalyNo longer taking part
  • Ospedale S. Maria della MisericordiaPerugia, ItalyNo longer taking part
  • Nuovo Ospedale Santo StefanoPrato, ItalyNo longer taking part
  • Ospedale "Maria Paternò Arezzo"Ragusa, ItalyNo longer taking part
  • Ospedale di RhoRho, ItalyNo longer taking part
  • Ospedale "Infermi" di RiminiRimini, ItalyNo longer taking part
  • Policlinico CasilinoRoma, ItalyNo longer taking part
  • Policlinico Umberto IRoma, ItalyNo longer taking part
  • Fondazione Policlinico Universitario Agostino GemelliRome, ItalyNo longer taking part
  • Presidio Ospedaliero Ospedale Sant'AnnaSan Fermo della Battaglia, ItalyNo longer taking part
  • Ospedale Civile SS. AnnunziataSavigliano, ItalyNo longer taking part
  • Ospedale BologniniSeriate, ItalyNo longer taking part
  • Azienda Ospedaliera S Maria Di TerniTerni, ItalyNo longer taking part
  • Ospedali Riuniti di AnconaTorrette, ItalyNo longer taking part
  • Ospedale di TrevisoTreviso, ItalyNo longer taking part

Trial details

Who runs it
Biotronik SE & Co. KG
Trial code
NCT02579889
Record updated
18 January 2024
Original description
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.Read full original descriptionShow less

Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease - B3 Study

The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence in a follow up period of 3 years, between Closed Loop Stimulation (CLS) ON versus OFF, on top of a DDD pacing in patients with pacemaker or ICD indication who require dual-chamber pacing due to sinus node disease (SND), with or without atrioventricular (AV) block.

Inclusion: Patients with Class I or II recommendations for permanent pacing due to SND, with or without AV block according to the current guidelines; Patients for whom dual-chamber pacing is indicated or preferred; Patients with an optimized and stable antiarrhythmic medical therapy at the time of enrolment; Closed Loop Stimulation function was not previously activated; No stroke events from implant; Patient implanted for the first time.

Exclusion: NYHA Class IV Heart Failure; Any indication to Cardiac Resynchronization Therapy (CRT); Atrial fibrillation ablation (left pulmonary veins) or other cardiac surgery < 3 m; Permanent AF (PermAF); Stage V kidney dysfunction; Life expectancy < 1; Minors; Pregnant or breast-feeding patients; Participation in another interventional trial.

ClinicalTrials.gov NCT02579889