Cardiogenic ShockDOUBLE-SHOCKNCT07762560
Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock
A study testing Microaxial flow pump (left ventricular assist device), Pulmonary artery catheter and Conventional hemodynamic monitoring in people with Cardiogenic Shock and Acute Myocardial Infarction (AMI), run by Leipzig Heart Science gGmbH at 1 site in Germany.
Trial summary
The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock, Acute Myocardial Infarction (AMI), Heart Failure, Acute
- What is being tested?
- Microaxial flow pump (left ventricular assist device), Pulmonary artery catheter and Conventional hemodynamic monitoring
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2026to Apr 2037
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:
- Planned immediate angiography and revascularization (preferred PCI)
- Systolic blood pressure <100 mmHg or catecholamines required to maintain pressure >90 mmHg during systole
- Arterial lactate >2.0 mmol/L
- Echocardiogram with LVEF <40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm
Who cannot join
- Age <18 and >80 years
- Shock duration >12 hours
- Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).
- Shock due to mechanical complication of AMI
- Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression >10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression <10 min are also eligible)
- After 390 included patients with OHCA, any OHCA will be an exclusion criterion
Show all 18Show fewer
- Any unwitnessed OHCA
- Refractory cardiac arrest with ongoing chest compression
- Evidence of severe right ventricular failure
- Severe aorta valve regurgitation/stenosis
- Severe peripheral arterial obstructive disease precluding mAFP placement
- Abnormalities of the aorta precluding mAFP device placement
- Presence of a mechanical aortic valve prosthesis
- Left ventricular thrombus
- Infective endocarditis
- Life expectancy <1 year due to comorbidities
- Mental disorder or language barrier that preclude informed consent
- Known pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Heart Center Leipzig at University of Leipzig
Leipzig, Saxony, 04289
About this study
Official title: Routine Microaxial Flow Pump Versus Radial Access Revascularization Without Routine Microaxial Flow Pump in Infarct-Related Cardiogenic Shock & Routine Pulmonary Artery Catheterization-based Monitoring With Protocolized Hemodynamic Optimization Versus Simplified Monitoring Without Protocolized Hemodynamic Optimization in Infarct-Related Cardiogenic Shock
The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).
The main questions it aims to answer are:
Read more
- Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?
- Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring?
Researchers will compare four treatment combinations to see if mechanical circulatory support and/or advanced hemodynamic monitoring reduce mortality in AMI-CS patients:
- Microaxial flow pump + pulmonary artery catheter
- Microaxial flow pump + conventional monitoring
- Medical therapy alone + pulmonary artery catheter
- Medical therapy alone + conventional monitoring
Participants will:
- Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups
- Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI
- Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring
- Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years
- Being tested
- Microaxial flow pump (left ventricular assist device), Pulmonary artery catheter, Conventional hemodynamic monitoring, Hemodynamic stabilization
- Keywords
- 2x2 factorial design, Mortality, Intensive care, Percutaneous coronary intervention, Hemodynamic monitoring, Mechanical circulatory support, Impella, Microaxial flow pump, AMI-CS, Acute myocardial infarction, Cardiogenic shock
- Medical subject headings
- Shock, Cardiogenic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microaxial flow pump (left ventricular assist device)Device
Percutaneous implantation of a left-sided microaxial flow pump via the femoral artery following PCI. The device actively unloads the left ventricle by aspirating blood from the left ventricle and ejecting it into the ascending aorta, thereby augmenting cardiac output. Implantation occurs immediately after PCI.
Pulmonary artery catheterDevice
Insertion of a pulmonary artery catheter via central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Measured parameters include cardiac output, pulmonary capillary wedge pressure (PCWP), and systemic and pulmonary vascular resistance.
Conventional hemodynamic monitoringProcedure or surgery
Standard intensive care hemodynamic monitoring without pulmonary artery catheter, including invasive arterial blood pressure measurement, central venous pressure monitoring, echocardiography, and serial laboratory parameters (e.g., lactate, creatinine, liver enzymes, blood count).
Hemodynamic stabilizationProcedure or surgery
Hemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter. Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and/or inotropes (e.g., dobutamine), administered according to current clinical guidelines. Dosage and duration are determined by the treating physician based on hemodynamic response. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Microaxial flow pump + pulmonary artery catheter | Experimental | Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include, e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance. Receives: Device: Microaxial flow pump (left ventricular assist device); Device: Pulmonary artery catheter |
| Microaxial flow pump + conventional monitoring | Experimental | Participants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted. Receives: Device: Microaxial flow pump (left ventricular assist device); Procedure: Conventional hemodynamic monitoring |
| Medical therapy + pulmonary artery catheter | Active comparator | Participants in this arm receive initial hemodynamic stabilization through guideline-recommended medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance. Receives: Device: Pulmonary artery catheter; Procedure: Hemodynamic stabilization |
| Medical therapy + conventional monitoring | Active comparator | Participants in this arm receive initial hemodynamic stabilization through guideline-directed medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted. All participants receive standard intensive care treatment as clinically indicated. Receives: Procedure: Conventional hemodynamic monitoring; Procedure: Hemodynamic stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause death
The primary outcome measure (endpoint) is the time to all-cause death during the first 180 days after randomization in all patients randomized.
Measured: 180 days after randomization
Secondary outcomes (17)
Lactate clearance
Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement.
Measured: 48 hours
Time to normalization of lactate
Time in hours to stable normalization of arterial lactate <2 mmol/l.
Measured: from date of randomization until the time in hours to stable normalization of arterial lactate <2 mmol/l.
Time to hemodynamic stabilization
Measured: Time to hemodynamic stabilization from randomization up to 4 weeks.
Need for escalation to (additional) MCS
Number of patients requiring escalation to (additional) MCS from randomization up to 4 weeks.
Measured: from date of randomization up to 4 weeks
Vasoactive-inotropic score (VIS)
The score has no metric; higher values indicate worse outcomes.
Measured: from randomization to ICU discharge which usually occurs within 4 weeks
Need for cardio-pulmonary resuscitation
Number of patients requiring cardiopulmonary resuscitation.
Measured: from date of randomization up to 4 weeks
Length of intensive care unit stay
Length of intensive care unit stay in days
Measured: from date of randomization to usually up to 4 weeks.
Length of hospitalization
Length of hospital stay in days
Measured: from date of randomization to usually up to 6 months
Quality of life (EuroQol 5D-5L)
Quality of life measured by the EuroQol 5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: 6month, 12 month after randomisation
Time to recurrent myocardial infarction
Measured: From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization
Time to rehospitalization for congestive heart failure
Measured: during the first 30 days, 6 and 12 months after randomization
Time to death
Measured: during the first 30 days and 12 months after randomization
Use of heart replacement therapy
Need for heart replacement therapy
Measured: from date of randomization up to 6 months.
Mortality and heart failure events
death, permanent LVAD/HTx and heart failure hospitalization
Measured: at 6 and 12 months
Implantable defibrillator
Need for implantable cardiac defibrillator
Measured: from date of randomization up to 12 months.
Health-related costs
Health related costs in € for each intervention.
Measured: from date of randomization to 6 months
Mortality
Measured: From randomization to death from any cause, assessed annually up to 10 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionApr 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leipzig Heart Science gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Boston Scientific Corporation, Heart Center Leipzig - University Hospital, Stiftung Institut fuer Herzinfarktforschung
- Responsible party
- Sponsor
- Investigators
- Holger Thiele, Prof. Dr. med., Principal investigator, Heart Center Leipzig at University of LeipzigJacob Eifer Møller, Prof DMSc, Principal investigator, Copenhagen University Hospital RighospitaletChristian Hassager, Prof. DMSc, Principal investigator, Copenhagen University Hospital, RigshospitaletAnne Freund, PD Dr. med., Principal investigator, Heart Center Leipzig at Leipzig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762560
- Sponsor's protocol ID
- DOUBLE-SHOCK Trial
- Acronym
- DOUBLE-SHOCK
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly. Access to de-identified data may be considered upon reasonable request and subject to approval by the study sponsor and applicable ethics committees.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Microaxial Flow Pump Versus Radial Access Revascularization Without Routine Microaxial Flow Pump in Infarct-Related Cardiogenic Shock & Routine Pulmonary Artery Catheterization-based Monitoring With Protocolized Hemodynamic Optimization Versus Simplified Monitoring Without Protocolized Hemodynamic Optimization in Infarct-Related Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07762560
- Acronym / sponsor ID
- DOUBLE-SHOCK / DOUBLE-SHOCK Trial
- Keywords
- 2x2 factorial design, Mortality, Intensive care, Percutaneous coronary intervention, Hemodynamic monitoring, Mechanical circulatory support, Impella, Microaxial flow pump
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Leipzig Heart Science gGmbHUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Boston Scientific Corporation, Heart Center Leipzig - University Hospital, Stiftung Institut fuer Herzinfarktforschung
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Apr 2037 (estimated)
- First posted
- 13 Aug 2026 (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 goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).
The main questions it aims to answer are:
- Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?
- Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring?
Researchers will compare four treatment combinations to see if mechanical circulatory support and/or advanced hemodynamic monitoring reduce mortality in AMI-CS patients:
- Microaxial flow pump + pulmonary artery catheter
- Microaxial flow pump + conventional monitoring
- Medical therapy alone + pulmonary artery catheter
- Medical therapy alone + conventional monitoring
Participants will:
- Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups
- Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI
- Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring
- Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Microaxial flow pump + pulmonary artery catheter | Experimental | Device: Microaxial flow pump (left ventricular assist device), Device: Pulmonary artery catheterParticipants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include, e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance. |
| Microaxial flow pump + conventional monitoring | Experimental | Device: Microaxial flow pump (left ventricular assist device), Procedure: Conventional hemodynamic monitoringParticipants in this arm undergo immediate implantation of a left-sided microaxial flow pump (Impella) via the femoral artery following percutaneous coronary intervention (PCI). The device is used to unload the left ventricle and augment cardiac output until hemodynamic stabilization is achieved. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted. |
| Medical therapy + pulmonary artery catheter | Active comparator | Device: Pulmonary artery catheter, Procedure: Hemodynamic stabilizationParticipants in this arm receive initial hemodynamic stabilization through guideline-recommended medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. In addition, participants receive a pulmonary artery catheter (PAC) inserted via a central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Target parameters include e.g., cardiac output, pulmonary capillary wedge pressure (PCWP), systemic and pulmonary vascular resistance. |
| Medical therapy + conventional monitoring | Active comparator | Procedure: Conventional hemodynamic monitoring, Procedure: Hemodynamic stabilizationParticipants in this arm receive initial hemodynamic stabilization through guideline-directed medical therapy following percutaneous coronary intervention (PCI), without immediate implantation of a mechanical circulatory support device. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. Hemodynamic monitoring is performed using conventional intensive care methods, including arterial blood pressure measurement, central venous catheter, echocardiography, and serial laboratory parameters. No pulmonary artery catheter is inserted. All participants receive standard intensive care treatment as clinically indicated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Planned immediate angiography and revascularization (preferred PCI)
- Systolic blood pressure <100 mmHg or catecholamines required to maintain pressure >90 mmHg during systole
- Arterial lactate >2.0 mmol/L
- Echocardiogram with LVEF <40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm
Key exclusion criteria (18 listed)
- Age <18 and >80 years
- Shock duration >12 hours
- Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).
- Shock due to mechanical complication of AMI
- Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression >10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression <10 min are also eligible)
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 |
|---|---|---|
| Microaxial flow pump (left ventricular assist device)Percutaneous implantation of a left-sided microaxial flow pump via the femoral artery following PCI. The device actively unloads the left ventricle by aspirating blood from the left ventricle and ejecting it into the ascending aorta, thereby augmenting cardiac output. Implantation occurs immediately after PCI. | Device | Microaxial flow pump + conventional monitoring, Microaxial flow pump + pulmonary artery catheter |
| Pulmonary artery catheterInsertion of a pulmonary artery catheter via central venous access (jugular, subclavian, or femoral vein) for continuous hemodynamic monitoring and protocol-based optimization of cardiovascular function. Measured parameters include cardiac output, pulmonary capillary wedge pressure (PCWP), and systemic and pulmonary vascular resistance. | Device | Medical therapy + pulmonary artery catheter, Microaxial flow pump + pulmonary artery catheter |
| Conventional hemodynamic monitoringStandard intensive care hemodynamic monitoring without pulmonary artery catheter, including invasive arterial blood pressure measurement, central venous pressure monitoring, echocardiography, and serial laboratory parameters (e.g., lactate, creatinine, liver enzymes, blood count). | Procedure or surgery | Medical therapy + conventional monitoring, Microaxial flow pump + conventional monitoring |
| Hemodynamic stabilizationHemodynamic stabilization without hemodynamic protocol by pulmonary artery catheter. Hemodynamic stabilization through intravenous vasoactive agents, including vasopressors (e.g., norepinephrine) and/or inotropes (e.g., dobutamine), administered according to current clinical guidelines. Dosage and duration are determined by the treating physician based on hemodynamic response. In case of refractory cardiogenic shock unresponsive to medical therapy, escalation to mechanical circulatory support is permitted at the discretion of the treating physician. | Procedure or surgery | Medical therapy + conventional monitoring, Medical therapy + pulmonary artery catheter |
Primary outcome
all-cause death
Time frame: 180 days after randomization
The primary outcome measure (endpoint) is the time to all-cause death during the first 180 days after randomization in all patients randomized.
17 secondary outcomes
Lactate clearance
Time frame: 48 hours
Time to normalization of lactate
Time frame: from date of randomization until the time in hours to stable normalization of arterial lactate <2 mmol/l.
Time to hemodynamic stabilization
Time frame: Time to hemodynamic stabilization from randomization up to 4 weeks.
Need for escalation to (additional) MCS
Time frame: from date of randomization up to 4 weeks
Vasoactive-inotropic score (VIS)
Time frame: from randomization to ICU discharge which usually occurs within 4 weeks
Need for cardio-pulmonary resuscitation
Time frame: from date of randomization up to 4 weeks
Length of intensive care unit stay
Time frame: from date of randomization to usually up to 4 weeks.
Length of hospitalization
Time frame: from date of randomization to usually up to 6 months
Quality of life (EuroQol 5D-5L)
Time frame: 6month, 12 month after randomisation
Time to recurrent myocardial infarction
Time frame: From randomization to recurrent myocardial infarction or end of follow-up, assessed at 30 days, 6 months, and 12 months after randomization
Time to rehospitalization for congestive heart failure
Time frame: during the first 30 days, 6 and 12 months after randomization
Time to death
Time frame: during the first 30 days and 12 months after randomization
Use of heart replacement therapy
Time frame: from date of randomization up to 6 months.
Mortality and heart failure events
Time frame: at 6 and 12 months
Implantable defibrillator
Time frame: from date of randomization up to 12 months.
Health-related costs
Time frame: from date of randomization to 6 months
Mortality
Time frame: From randomization to death from any cause, assessed annually up to 10 years after randomization
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 24 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly. Access to de-identified data may be considered upon reasonable request and subject to approval by the study sponsor and applicable ethics committees.
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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.
Holger Thiele, Prof. Dr. med. principal investigator
Heart Center Leipzig at University of Leipzig
Jacob Eifer Møller, Prof DMSc principal investigator
Copenhagen University Hospital Righospitalet
Christian Hassager, Prof. DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microaxial flow pump (left ventricular assist device), Pulmonary artery catheter and Conventional hemodynamic monitoring in people with Cardiogenic Shock and Acute Myocardial Infarction (AMI), run by Leipzig Heart Science gGmbH 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 5 inclusion and 18 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: opening soon, as of the sponsor's last update on 24 Aug 2026. 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?
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 DOUBLE SHOCK Leipzig Heart Science gGmbH (+49 341 865 251542, DOUBLE-SHOCK@leipzig-heart.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause death (time frame: 180 days after randomization). 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 24 Aug 2026.