Registry for monitoring cardiac device performance and safety
BoStOn SCientific Rhythm MAnagemenT REgiStry
This study is collecting information on how well Boston Scientific heart devices work and their safety for patients who have recently had procedures with these devices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12500 (estimated) |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 26 sites (Jette and 25 other locations) |
| Trial ID | NCT04823663 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for or recently treated with Boston Scientific electrophysiology or cardiac rhythm management devices.
Not a fit: Patients who are not undergoing procedures involving Boston Scientific devices or who will not be followed for at least one year post-implant may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the safety and effectiveness of cardiac devices, leading to improved patient outcomes.
How similar studies have performed: Other post-market surveillance studies have shown success in improving device safety and performance monitoring, indicating that this approach is validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jette and 25 other locations
- 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)
- CHG de Pau — Pau, France (Recruiting)
- CHU de Saint-Etienne — Saint-Etienne, France (Recruiting)
- Unfallkrankenhaus Berlin Marzahn — Berlin, Germany (Recruiting)
- Augusta Kranken Anstalt GmbH — Bochum, Germany (Completed)
- General Hospital of Athens "G. Gennimatas" — Athens, Greece (Completed)
- Onassis Cardiac Surgery Center — Athens, Greece (Recruiting)
- Mater Private Hospital — Dublin, Ireland (Recruiting)
- Sheba Medical Center — Ramat Gan, Israel (Recruiting)
- Tel Aviv Sourask Medical Center — Tel Aviv, Israel (Recruiting)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- Policlinico di Modena — Modena, Italy (Recruiting)
- Policlinico Universitario Agostino Gemelli — Roma, Italy (Recruiting)
- Policlinico Casilino — Roma, Italy (Recruiting)
- Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina — Roma, Italy (Recruiting)
- Hospital Clinico San Carlos — Madrid, Spain (Recruiting)
- Hospital Universitario de Canarias — San Cristóbal de La Laguna, Spain (Recruiting)
- Hospital Nuestra Señora de La Candelaria — Santa Cruz de Tenerife, Spain (Recruiting)
- Hospital Universitario Miguel Servet — Zaragoza, Spain (Recruiting)
- St. Bartholomew's Hospital — London, United Kingdom (Recruiting)
- Manchester Heart Center — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Maria Paz Lopez-Chicharro
- Email: maria.lopez-chicharro@bsci.com
- Phone: 1-800-227-3422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.