BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)
Recruiting now
Conditions studied: Cardiac Disease
In brief
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.
Key facts
- Study ID
- NCT04823663
- Run by
- Boston Scientific Corporation
- People needed
- 12500
- Starts
- 2021-03-31
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-07-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is willing and capable of providing informed consent and/or to give approval to collect/store/process personal health information by the sponsor or such consent/approval is provided by a legally designated representative, if required by local law or regulation.
- Subject is (one criterion must be fulfilled) a. prospectively scheduled for a procedure involving i. use of a BSC EP Ablation product or BSC Capital Equipment product or ii. a BSC CRM product implant or b. retrospectively enrolled no more than 10 days after the index procedure and all data necessary for appropriate reporting of all past visits is available and complete including i. the procedure where being diagnosed or treated with at least 3 separate BSC EP Ablation products/components or BSC Capital Equipment products/components or ii. the BSC CRM product implant.
You may not qualify if…
- Subject is foreseen not to be followed at the enrolling center for at least 1 year after an implant procedure (CRM) or at least 1 month (EP).
- Subject is receiving diagnosis or therapy by means of any product, that is not approved for commercial use at the time of implant/procedure.
Where it is running
- Manchester Heart Center — Manchester, United Kingdom (enrolling)
- CHU UCL Namur - Site Godinne — Yvoir, Belgium (enrolling)
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec — Québec, Quebec, Canada (enrolling)
- CHRU de Brest, Hôpital de la Cavale Blanche — Brest, France (enrolling)
- CHRU de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- Hopital Saint Philibert — Lomme, France (enrolling)
- CHG de Pau — Pau, France (enrolling)
- CHU de Saint-Etienne — Saint-Etienne, France (enrolling)
- Unfallkrankenhaus Berlin Marzahn — Berlin, Germany (enrolling)
- St. Bartholomew's Hospital — London, United Kingdom (enrolling)
- Universitair Ziekenhuis Brussel — Jette, Belgium (enrolling)
- Onassis Cardiac Surgery Center — Athens, Greece (enrolling)
- Mater Private Hospital — Dublin, Ireland (enrolling)
- Sheba Medical Center — Ramat Gan, Israel (enrolling)
- Tel Aviv Sourask Medical Center — Tel Aviv, Israel (enrolling)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (enrolling)
- Policlinico di Modena — Modena, Italy (enrolling)
- Policlinico Universitario Agostino Gemelli — Roma, Italy (enrolling)
- Policlinico Casilino — Roma, Italy (enrolling)
- Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina — Roma, Italy (enrolling)
- Hospital Clinico San Carlos — Madrid, Spain (enrolling)
- Hospital Universitario de Canarias — San Cristóbal de La Laguna, Spain (enrolling)
- Hospital Nuestra Señora de La Candelaria — Santa Cruz de Tenerife, Spain (enrolling)
- Hospital Universitario Miguel Servet — Zaragoza, Spain (enrolling)
- Augusta Kranken Anstalt GmbH — Bochum, Germany
Full record on ClinicalTrials.gov
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