BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES) (SOCRATES)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04823663 |
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Recruitment Status :
Recruiting
First Posted : April 1, 2021
Last Update Posted : March 10, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Cardiac Disease | Device: Implant Procedure: Electrophysiologic procedure |
SOCRATES is a non-randomized, multisite, single-arm, open-label, global post-market observational data collection per standard of care. While generally of prospective design, a limited retrospective element is allowed for the inclusion of patients for a short period of 10 days after their index procedure.
SOCRATES intends to enroll a number of subjects that will support the analysis of all the individual PMCF Plans. An average of approximately 100 subjects per year and site on a continuous basis is expected but may vary depending on the needs of individual PMCF Plans. As long as SOCRATES is active, there is no upper limit to the total number of subjects that may be enrolled, and enrollment will be driven by the need to support sample sizes of individual PMCF plans for given products/product groupings supported by SOCRATES.
SOCRATES is designed to be a continuous effort after the data collection commences without a predefined closure timepoint. Data collection and enrollment may be stopped, restarted or finalized per Sponsor discretion.
The expected duration of SOCRATES participation for a subject is dependent on
- the specific lifetime of the device (e.g. the battery usage for pulse generators or continued active use of leads for CRM devices) or
- the necessary timeframe to adequately assess safety and performance of the device based on the residual risk assessed for each device in the associated PMCF plan. Timeframes might e.g. spread from 7 days to one year post procedure for EP. The maximum duration per enrolled subject will consequently vary.
For BSC implantable devices subjects are intended to be followed for the entire time of being implanted with a BSC device to allow data collection over the lifetime of the device(s) as required by applicable regulations. A maximum duration per enrolled subject is not defined, unless locally required. In case a local maximum duration is enforced subjects may be consented again and re-enrolled for continued participation if they are still in scope for SOCRATES. Sites shall ensure continuous data collection without any gaps in case a re-enrollment becomes applicable. Data sets for re-enrolled subjects will be handled as if the subject was continuously enrolled. This process will ensure to meet the requirement of MDR for device manufacturers to collect data over the lifetime of the devices.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 12500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 10 Years |
| Official Title: | BoStOn SCientific Rhythm MAnagemenT REgiStry |
| Actual Study Start Date : | March 31, 2021 |
| Estimated Primary Completion Date : | December 31, 2030 |
| Estimated Study Completion Date : | December 31, 2030 |
| Group/Cohort | Intervention/treatment |
|---|---|
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BSC Product Use
Subject fulfilling one of the following conditions: 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 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. |
Device: 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. Procedure: 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. |
- System-related complication free rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: CRM implant on day 0 through the implanted duration up to 10 years ]Performance of product/product group through the implanted duration
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- Subject is receiving diagnosis or therapy by means of any product, that is not approved for commercial use at the time of implant/procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823663
| Contact: Jens Goetzke, Dipl.Ing. | +32 2 41 ext 67011 | Jens.Goetzke@bsci.com |
| Belgium | |
| Universitair Ziekenhuis Brussel | Recruiting |
| Jette, Belgium, 1090 | |
| Contact: Carlo de Asmundis, Prof. | |
| France | |
| Hopital Saint Philibert | Recruiting |
| Lomme, France, 59462 | |
| Contact: Aymeric Menet, MD | |
| CHG de Pau | Recruiting |
| Pau, France | |
| Contact: Hugues Bader, MD | |
| Germany | |
| Unfallkrankenhaus Berlin Marzahn | Not yet recruiting |
| Berlin, Germany, 12687 | |
| Contact: Corinna Lenz, MD | |
| Augusta Kranken Anstalt GmbH | Recruiting |
| Bochum, Germany, 44791 | |
| Contact: Magnus Prull, MD | |
| Israel | |
| Sheba Medical Center | Not yet recruiting |
| Ramat-Gan, Israel, 52621 | |
| Contact: Roy Beinart, MD | |
| Italy | |
| Policlinico Universitario Agostino Gemelli | Recruiting |
| Roma, Italy, 00168 | |
| Contact: Gemma Pelargonio, MD | |
| Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina | Recruiting |
| Roma, Italy, 00186 | |
| Contact: Stefano Bianchi, MD | |
| United Kingdom | |
| Manchester Heart Center | Recruiting |
| Manchester, United Kingdom, M13 9WL | |
| Contact: Amir Zaidi, MD | |
| Study Director: | Ezter Pais, MD | Boston Scientific Corporation |
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT04823663 |
| Obsolete Identifiers: | NCT04828811 |
| Other Study ID Numbers: |
C2157 |
| First Posted: | April 1, 2021 Key Record Dates |
| Last Update Posted: | March 10, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Heart Diseases Cardiovascular Diseases |