ClinicaliQ Trial Snapshot
- BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES) — Recruiting • Cardiology / Cardiovascular • NCT04823663.
- What is being tested: SOCRATES is a post-market surveillance registry monitoring Boston Scientific's rhythm management devices (pacemakers, defibrillators, and related systems) to evaluate real-world safety, efficacy, and performance outcomes in clinical practice.
- Patient eligibility overview: The registry includes patients who have received Boston Scientific rhythm management implants across participating centres, typically encompassing broad patient populations with arrhythmias and cardiac conduction disorders requiring device therapy, with inclusion criteria reflecting routine clinical practice settings.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
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- 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.