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12,500 patients enrolled in massive heart device safety check

NCT ID NCT04823663

Knowledge-focused Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 25, 2026 · Updated 7 times

Summary

This registry is a large-scale effort to monitor the safety and performance of Boston Scientific cardiac devices, including pacemakers and ablation tools, in 12,500 patients. It collects data from routine procedures and follow-ups to see how well the devices work and if any complications arise. No new treatment is being tested—this is about gathering real-world evidence to meet regulatory requirements.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 12,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The subjects will be recruited from the general patient population of the participating centers who are * receiving diagnosis or treatment using a BSC product in scope of SOCRATES and * fulfilling all inclusion criteria and none of the exclusion criteria.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

heart disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Augusta Kranken Anstalt GmbH

    COMPLETED

    Bochum, 44791, Germany

  • CHG de Pau

    RECRUITING

    Pau, France

  • CHRU de Brest, Hôpital de la Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • CHRU de Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, 63000, France

  • CHU UCL Namur - Site Godinne

    RECRUITING

    Yvoir, 5530, Belgium

  • CHU de Saint-Etienne

    RECRUITING

    Saint-Etienne, 42055, France

  • General Hospital of Athens "G. Gennimatas"

    COMPLETED

    Athens, 11527, Greece

  • Hopital Saint Philibert

    RECRUITING

    Lomme, 59462, France

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Nuestra Señora de La Candelaria

    RECRUITING

    Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario de Canarias

    RECRUITING

    San Cristóbal de La Laguna, 38320, Spain

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Manchester Heart Center

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Mater Private Hospital

    RECRUITING

    Dublin, D07 WKW8, Ireland

  • Onassis Cardiac Surgery Center

    RECRUITING

    Athens, 17674, Greece

  • Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina

    RECRUITING

    Roma, 00186, Italy

  • Policlinico Casilino

    RECRUITING

    Roma, 00169, Italy

  • Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Policlinico di Modena

    RECRUITING

    Modena, 41124, Italy

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 52621, Israel

  • St. Bartholomew's Hospital

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Tel Aviv Sourask Medical Center

    RECRUITING

    Tel Aviv, 62431, Israel

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Unfallkrankenhaus Berlin Marzahn

    RECRUITING

    Berlin, 12687, Germany

  • Universitair Ziekenhuis Brussel

    RECRUITING

    Jette, 1090, Belgium

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