Brief Summary

SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.

Conditions

• Cardiac Disease

Intervention / Treatment

• Device: Implant
• Procedure: Electrophysiologic procedure

Primary Outcome Measures

• System-related complication free rate (From Cardiac Rhythm Management (CRM) device implant on day 0 through follow-up up to 10 years; from electrophysiological (EP) procedure on day 0 through follow-up from 30 days up to 1 year)
  Freedom from complications related to system
• Rate of product related performance deficiencies per product or product group (CRM implant on day 0; EP procedure on day 0)
  Performance of product/product group at implant/procedure
• Rate of product related performance deficiencies per product or product group (CRM implant on day 0 through the implanted duration up to 10 years)
  Performance of product/product group through the implanted duration

Countries

Belgium, Canada, France, Germany, Greece, Ireland, Israel, Italy, Spain, United Kingdom

Locations and Investigators

• Universitair Ziekenhuis Brussel, Jette, Belgium (Recruiting)
  • Carlo de Asmundis, Prof.
• CHU UCL Namur - Site Godinne, Yvoir, Belgium (Recruiting)
  • Dominique Blommaert, Prof.
• Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Québec, Canada (Recruiting)
  • Jean-Francois Sarrazin, MD
• CHRU de Brest, Hôpital de la Cavale Blanche, Brest, France (Recruiting)
  • Jacques Mansourati, Prof.
• CHRU de Clermont-Ferrand, Clermont-Ferrand, France (Recruiting)
  • Romain Eschalier, MD
• Hopital Saint Philibert, Lomme, France (Recruiting)
  • Aymeric Menet, MD
• CHG de Pau, Pau, France (Recruiting)
  • Hugues Bader, MD
• CHU de Saint-Etienne, Saint-Etienne, France (Recruiting)
  • Antoine Da Costa, Prof.
• Unfallkrankenhaus Berlin Marzahn, Berlin, Germany (Recruiting)
  • Corinna Lenz, MD
• Augusta Kranken Anstalt GmbH, Bochum, Germany (Completed)
• General Hospital of Athens "G. Gennimatas", Athens, Greece (Completed)
• Onassis Cardiac Surgery Center, Athens, Greece (Recruiting)
  • Michael Ephremidis, MD
• Mater Private Hospital, Dublin, Ireland (Recruiting)
  • Gabor Szeplaki, Prof.
• Sheba Medical Center, Ramat Gan, Israel (Recruiting)
  • Roy Beinart, MD
• Tel Aviv Sourask Medical Center, Tel Aviv, Israel (Recruiting)
  • Raphael Rosso, Professor
• Tel Aviv Sourasky Medical Center, Tel Aviv, Israel (Recruiting)
  • Raphael Rosso, Professor
• Policlinico di Modena, Modena, Italy (Recruiting)
  • Giuseppe Boriani, Prof.
• Policlinico Universitario Agostino Gemelli, Roma, Italy (Recruiting)
  • Gemma Pelargonio, MD
• Policlinico Casilino, Roma, Italy (Recruiting)
  • Leonardo Calò, MD
• Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina, Roma, Italy (Recruiting)
  • Stefano Bianchi, MD
• Hospital Clinico San Carlos, Madrid, Spain (Recruiting)
  • Nicasio Pérez Castellano, MD
• Hospital Universitario de Canarias, San Cristóbal de La Laguna, Spain (Recruiting)
  • Francisco Bosa Ojeda, MD
• Hospital Nuestra Señora de La Candelaria, Santa Cruz de Tenerife, Spain (Recruiting)
  • Luis A. Acosta, MD
• Hospital Universitario Miguel Servet, Zaragoza, Spain (Recruiting)
  • Antonio Asso Abadía, MD
• St. Bartholomew's Hospital, London, United Kingdom (Recruiting)
  • Ross Hunter, Prof.
• Manchester Heart Center, Manchester, United Kingdom (Recruiting)
  • Charles Pearman, MD

Study Officials

• Eszter Pais, MD (Study Director) — Boston Scientific Corporation