Cardiovascular DiseasesSYMBIOSISNCT04241328
Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery
An observational study of Cardiovascular Diseases, run by Medtronic Cardiac Surgery at 14 sites in 8 countries.
Trial summary
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 5,000 participants
- Where
- 14 sitesin 8 countries
- Study dates
- 9 Jan 2020to 31 Dec 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive subjects with the intent of being treated or treated (up to discharge from treating hospital) with a market-approved Medtronic CS product, are candidates to be enrolled. The Investigator will determine subject eligibility in SYMBIOSIS based upon the inclusion/exclusion criteria. If a subject meets all inclusion and none of the exclusion criteria, they will be informed about the SYMBIOSIS Registry. SYMBIOSIS will collect data of numerous patient conditions for which Medtronic CS products are being used.
Who may be able to join
- Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital.
- Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.
Who cannot join
- Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry
Trial locations and contacts
14 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 8 countries
Germany3 sites, 3 recruiting
- Recruiting
Uniklinik RWTH Aachen
Aachen
Prof. Dr. Dodge Khatami
- Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Jan Gummert, Professor
- Recruiting
Deutsches Herzzentrum München
Munich, 80636
Keti Vitanova, Dr. med.
Netherlands3 sites, 1 recruiting
- Completed
Catharina Ziekenhuis
Eindhoven, 5623 EJ
- Active, not recruiting
Maastricht University Medical Center (MUMC+)
Maastricht, 6229 HX
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein
Dr. Guillaume Geuzebroek
Belgium2 sites
- Completed
Ziekenhuis Oost-Limburg
Genk, 3600
- Completed
UZ Leuven
Leuven
France2 sites
- Completed
CHU d'Angers
Angers
- Terminated
Clinique Claude Bernard
Metz, 57070
Austria1 site, 1 recruiting
- Recruiting
AKH Wien
Vienna, 1090
D Wiedemann, Prof. Dr.
About this study
Official title: SYMBIOSIS Post-Market Registry
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.
Read the detailed description
The objective is to collect product safety and performance data for Medtronic CE (Conformitè Europëenne )-Marked Cardiac Surgery, including perfusion (CS) products.
The main goals of this data collection are as follows:
- Identification of any (new) device-related complications including events which were not anticipated or documented in the Instructions For Use (IFU), or Risk Management Plan, or Clinical Evidence Evaluation report, or Design Failure Modes and Effect Analysis
- Evaluation of device success defined as the absence of any probable or causal device-related adverse events or device deficiencies
- Evaluation of general device performance when applicable
Subjects are enrolled and, if applicable, followed according to routine care practices at their treating hospital.
Inclusion Criteria:
- Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating Registry hospital.
- Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.
Exclusion Criteria:
- Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry
Data collection includes, for example:
- Demographics
- Product performance information
- Safety Events
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Safety
Procedure- , device-related events and device deficiencies
Measured: Procedural
Device performance
Device Success
Measured: Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start9 Jan 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241328
- Sponsor's protocol ID
- MDT19022PMF001
- Acronym
- SYMBIOSIS
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2020
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYMBIOSIS Post-Market Registry
- ClinicalTrials.gov ID
- NCT04241328
- Acronym / sponsor ID
- SYMBIOSIS / MDT19022PMF001
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Medtronic Cardiac SurgeryIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.
Detailed description
The objective is to collect product safety and performance data for Medtronic CE (Conformitè Europëenne )-Marked Cardiac Surgery, including perfusion (CS) products.
The main goals of this data collection are as follows:
- Identification of any (new) device-related complications including events which were not anticipated or documented in the Instructions For Use (IFU), or Risk Management Plan, or Clinical Evidence Evaluation report, or Design Failure Modes and Effect Analysis
- Evaluation of device success defined as the absence of any probable or causal device-related adverse events or device deficiencies
- Evaluation of general device performance when applicable
Subjects are enrolled and, if applicable, followed according to routine care practices at their treating hospital.
Inclusion Criteria:
- Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating Registry hospital.
- Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.
Exclusion Criteria:
- Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry
Data collection includes, for example:
- Demographics
- Product performance information
- Safety Events
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive subjects with the intent of being treated or treated (up to discharge from treating hospital) with a market-approved Medtronic CS product, are candidates to be enrolled. The Investigator will determine subject eligibility in SYMBIOSIS based upon the inclusion/exclusion criteria. If a subject meets all inclusion and none of the exclusion criteria, they will be informed about the SYMBIOSIS Registry. SYMBIOSIS will collect data of numerous patient conditions for which Medtronic CS products are being used.
Key inclusion criteria (2 listed)
- Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital.
- Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.
Key exclusion criteria (1 listed)
- Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device Safety
Time frame: Procedural
Procedure- , device-related events and device deficiencies
Device performance
Time frame: Procedural
Device Success
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Medtronic Cardiac Surgery at 14 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Netherlands, Belgium, France, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Lindelauf, BSc (+31611605434, lisa.lindelauf@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Safety (time frame: Procedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.