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Clinical Trials in Italy / NCT04823663
Recruiting Observational

BoStOn SCientific Rhythm MAnagemenT REgiStry

NCT04823663 · tracked via the Priya Life Science Italy tracker
Sponsor
Boston Scientific Corporation
Phase
Observational
Started
2021-03-31
Last updated
2026-09-25

Condition(s) studied

Cardiac Disease

Investigational drug(s) / intervention(s)

ImplantElectrophysiologic procedure

Implant: In the scope of the CRM procedure and subsequent follow-up, the registry will provide information on the use of the Boston Scientific CRM products/components and combination of those products/components with competitor product(s) per hospital's standard of care.

Electrophysiologic procedure: In the scope of the EP procedure and subsequent follow-up, the registry will provide information on the use of the Boston Scientific Electrophysiology products/components and capital equipment products and combination of those products/components with competitor product(s) per hospital's standard of care.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (26)

FacilityCityRegionStatus
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 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

More Boston Scientific Corporation trials in Italy

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Active, not recruiting
ACURATE neo2™ Post Market Clinical Follow up Study Active, not recruiting
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
WATCHMAN FLX Pro European Registry Active, not recruiting
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation Active, not recruiting

Other trials for the same condition

Digital diagnoSis of Cardiac sOUNd in peDiatric Patients [DI-SOUND Study] Recruiting
Predicting Cerebrovascular Adverse Events Post Cardiac Surgery Recruiting
Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay Recruiting
Dynamic Cardio-vascular, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects Recruiting
Utility of Gene Test Analysis for Diagnosis, Prognosis and Treatment of Patients With Genetic Arrhythmic Heart Disease: the ARRHYTHMIC GENE-HEART Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04823663 on ClinicalTrials.gov ↗ ← All trials in Italy