Shock, CardiogenicNCT02697006
Synchronized Cardiac Assist for Cardiogenic Shock
An observational study of Shock, Cardiogenic and High Risk Percutaneous Coronary Interventions, run by Xenios AG at 1 site in Germany.
Trial summary
The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shock, Cardiogenic, High Risk Percutaneous Coronary Interventions
- What is being tested?
- i-cor Synchronized Cardiac Assist Device
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to 16 Feb 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cardiogenic shock or in high risk percutaneous intervention procedures in the cardiac catheterization lab
Who may be able to join
- Patients in cardiogenic shock in the setting of acute myocardial infarction
- or
- Patients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, left main, or last patent conduit interventions) in the catheterization lab.
- Cardiogenic shock is defined as
- Systolic blood pressure < 90 mmHg for at least 30 min or
- Inotropes are needed to maintain blood pressure > 90 mmHg or
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- Clinical signs of heart insufficiency with pulmonary congestion or
- Signs of end organ hypoperfusion with at least one of the following criteria:
- Altered mental status
- cold, damp skin or extremities
- oliguria (≤ 30 mL/h)
- serum lactate > 2.0 mmol/L
- Written consent of the patient or the legal caregiver
- -
Who cannot join
- Age > 85 years
- Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 10 min
- Coma with fixed pupils not induced by drugs;
- Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
- Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
- Fever (Body temperature > 38.0 °C) or other evidence of sepsis
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- Onset of cardiogenic shock > 6 h before enrollment;
- Lactate > 22 mmol/L;
- Massive pulmonary embolism;
- Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
- Previous known aortic regurgitation greater than grade II
- Contra-indications for anticoagulation
- Severe hemolysis of any cause
- Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial
The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.
- Being tested
- i-cor Synchronized Cardiac Assist Device
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-cor Synchronized Cardiac Assist DeviceDevice
The i-cor Synchronized Cardiac Assist Device delivers pulsatile cardiac assist synchronized to the ECG during diastole and provides enhanced oxygenation through a membrane oxygenator.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Device and Procedure Related Serious Adverse Events
Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.
Measured: 30 days
Number of Participants Treated With Technical Success of the Device
Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).
Measured: 24 hours
Number of Participants With Device Performance Success
Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startJan 2016
- Primary completion30 Apr 2018
- Study completion16 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shock, CardiogenicStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenios AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Christoph Liebetrau, Dr. med., Principal investigator, Kerckhoff Klinik, Cardiology, Bad Nauheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697006
- Sponsor's protocol ID
- Protocol 1.1 Version 1.0
- Status last verified
- Sep 2020
- First submitted
- 22 Feb 2016
- Last updated
- 16 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial
- ClinicalTrials.gov ID
- NCT02697006
- Acronym / sponsor ID
- Protocol 1.1 Version 1.0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Xenios AGIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- Jan 2016
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 16 Feb 2019 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Posted 16 Sep 2022
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 study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiogenic shock or in high risk percutaneous intervention procedures in the cardiac catheterization lab
Key inclusion criteria (14 listed)
- Patients in cardiogenic shock in the setting of acute myocardial infarction
- or
- Patients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, left main, or last patent conduit interventions) in the catheterization lab.
- Cardiogenic shock is defined as
- Systolic blood pressure < 90 mmHg for at least 30 min or
Key exclusion criteria (14 listed)
- Age > 85 years
- Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 10 min
- Coma with fixed pupils not induced by drugs;
- Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
- Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-cor Synchronized Cardiac Assist DeviceThe i-cor Synchronized Cardiac Assist Device delivers pulsatile cardiac assist synchronized to the ECG during diastole and provides enhanced oxygenation through a membrane oxygenator. | Device | – |
Primary outcome
Number of Participants With Device and Procedure Related Serious Adverse Events
Time frame: 30 days
Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.
Number of Participants Treated With Technical Success of the Device
Time frame: 24 hours
Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).
Number of Participants With Device Performance Success
Time frame: 7 days
Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Christoph Liebetrau, Dr. med. principal investigator
Kerckhoff Klinik, Cardiology, Bad Nauheim, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, Cardiogenic and High Risk Percutaneous Coronary Interventions, run by Xenios AG at 1 site in Germany.
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 14 inclusion and 14 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: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device and Procedure Related Serious Adverse Events (time frame: 30 days). The study lists 3 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 16 Sep 2022.