Registry for monitoring cardiac device performance and safety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SOCRATES is an observational registry designed to systematically collect and analyze data on the quality, performance, and safety of Boston Scientific cardiac devices throughout their lifecycle. This non-randomized, multisite, single-arm study will enroll patients who are either scheduled for or have recently undergone procedures involving specific Boston Scientific products. The registry aims to support post-market clinical follow-up plans by gathering data continuously, with no predefined closure timepoint, allowing for ongoing assessment of device safety and performance. Participation duration varies based on the specific device used and its operational lifetime.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

1. 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).
2. 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's running

• Universitair Ziekenhuis Brussel
  Jette, Belgium Recruiting
• CHU UCL Namur - Site Godinne
  Yvoir, Belgium Recruiting
• Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  Québec, Quebec, Canada Recruiting
• CHRU de Brest, Hôpital de la Cavale Blanche
  Brest, France Recruiting
• CHRU de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Hopital Saint Philibert
  Lomme, France Recruiting

Study contacts

• Study coordinator: Maria Paz Lopez-Chicharro
• Email: maria.lopez-chicharro@bsci.com
• Phone: 1-800-227-3422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.