Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock (DOUBLE-SHOCK)

August 20, 2026 updated by: Leipzig Heart Science gGmbH

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:

  • 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
780

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Saxony
      • Leipzig, Saxony, Germany, 04289
        • Heart Center Leipzig at University of Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:

  1. Planned immediate angiography and revascularization (preferred PCI)
  2. Systolic blood pressure <100 mmHg or catecholamines required to maintain pressure >90 mmHg during systole
  3. Arterial lactate >2.0 mmol/L
  4. Echocardiogram with LVEF <40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm

Exclusion Criteria:

  1. Age <18 and >80 years
  2. Shock duration >12 hours
  3. Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).
  4. Shock due to mechanical complication of AMI
  5. 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)
  6. After 390 included patients with OHCA, any OHCA will be an exclusion criterion
  7. Any unwitnessed OHCA
  8. Refractory cardiac arrest with ongoing chest compression
  9. Evidence of severe right ventricular failure
  10. Severe aorta valve regurgitation/stenosis
  11. Severe peripheral arterial obstructive disease precluding mAFP placement
  12. Abnormalities of the aorta precluding mAFP device placement
  13. Presence of a mechanical aortic valve prosthesis
  14. Left ventricular thrombus
  15. Infective endocarditis
  16. Life expectancy <1 year due to comorbidities
  17. Mental disorder or language barrier that preclude informed consent
  18. Known pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Microaxial flow pump + pulmonary artery catheter
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.
Device: 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: Pulmonary artery catheter
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.
Experimental: Microaxial flow pump + conventional monitoring
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.
Device: 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.
Procedure: Conventional hemodynamic monitoring
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).
Active Comparator: Medical therapy + pulmonary artery catheter
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.
Device: Pulmonary artery catheter
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.
Procedure: Hemodynamic stabilization
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.
Active Comparator: Medical therapy + conventional monitoring
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.
Procedure: Conventional hemodynamic monitoring
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).
Procedure: Hemodynamic stabilization
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
180 days after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lactate clearance
Time Frame: 48 hours
Number of participants with reduction in arterial lactate measurement from baseline to 48 hours measurement.
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 in hours to stable normalization of arterial lactate <2 mmol/l.
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.
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
Number of patients requiring escalation to (additional) MCS from randomization up to 4 weeks.
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
The score has no metric; higher values indicate worse outcomes.
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
Number of patients requiring cardiopulmonary resuscitation.
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 intensive care unit stay in days
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
Length of hospital stay in days
from date of randomization to usually up to 6 months
Quality of life (EuroQol 5D-5L)
Time Frame: 6month, 12 month after randomisation
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.
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
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
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
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.
Need for heart replacement therapy
from date of randomization up to 6 months.
Mortality and heart failure events
Time Frame: at 6 and 12 months
death, permanent LVAD/HTx and heart failure hospitalization
at 6 and 12 months
Implantable defibrillator
Time Frame: from date of randomization up to 12 months.
Need for implantable cardiac defibrillator
from date of randomization up to 12 months.
Health-related costs
Time Frame: from date of randomization to 6 months
Health related costs in € for each intervention.
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
From randomization to death from any cause, assessed annually up to 10 years after randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sustained ventricular arrhythmia requiring cardioversion
Time Frame: from date of randomization up to usually 4 weeks
Sustained ventricular arrhythmia requiring cardioversion
from date of randomization up to usually 4 weeks
Bradycardia with pacing requirement
Time Frame: from date of randomization up to usually 4 weeks.
Bradycardia requiring pacing.
from date of randomization up to usually 4 weeks.
Acute kidney injury according to KDIGO criteria
Time Frame: from date of randomization up to usually 4 weeks.
Acute kidney injury according to KDIGO criteria
from date of randomization up to usually 4 weeks.
Creatinine clearance (assessed by eGFR)
Time Frame: From randomization to 72 hours after randomization
From randomization to 72 hours after randomization
Requirement for renal replacement therapy
Time Frame: from date of randomization up to usually 4 weeks.
Acute kidney injury requiring renal replacement therapy.
from date of randomization up to usually 4 weeks.
Major bleeding according to BARC definition (BARC 3-5)
Time Frame: from date of randomization up to usually 4 weeks
Major bleeding according to BARC 3-5 criteria.
from date of randomization up to usually 4 weeks
Cumulative transfusion need
Time Frame: from date of randomization up to 4 weeks.
Number of red packed blood cells for transfusion per patient .
from date of randomization up to 4 weeks.
Vascular access site related complications
Time Frame: from date of randomization up to 4 weeks.
Number of vascular access site related complications.
from date of randomization up to 4 weeks.
Significant hemolysis
Time Frame: from date of randomization up to usually 4 weeks.

Significant hemolysis is defined as a plasma free hemoglobin >20 mg/dL (or an increase of 20 mg/dL above baseline values before initiation of support) and at least one of the following clinical findings occurring within 72 hours after initiation of support or within 24 (±2) hours of device removal:

  • Presence of hemoglobinuria ("tea-colored urine") with exclusion of gross hematuria
  • New or worsening anemia defined as an absolute decrease in hematocrit by 10% or hemoglobin level by 3 g/dL not explained by other clinical factors.
  • Hyperbilirubinemia defined as a total bilirubin above 2 mg/dl (predominately indirect component)
  • Creatinine increasing by greater than 50% above baseline or the need for new dialysis not explained by other clinical factors.
  • Device malfunction or abnormal pump parameters
from date of randomization up to usually 4 weeks.
Sepsis with positive blood cultures
Time Frame: from date of randomization up to usually 4 weeks.

Sepsis is defined as: Sepsis is caused by the immune system's response to a serious infection, most commonly bacteria, but also fungi, viruses, and parasites in the blood, urinary tract, lungs, skin, or other tissues. It will be defined as:

Positive blood cultures and two or more of the following (SEPSIS-3 criteria):

  1. Low blood pressure (SBP ≤100 mmHg),
  2. High respiratory rate (≥22 breaths per min), or
  3. Altered mentation (Glasgow coma scale <15) (quick SOFA)
from date of randomization up to usually 4 weeks.
Stroke
Time Frame: from date of randomization up to usually 4 weeks.

Stroke will be classified in hemorrhagic (cranial CT, MRI, or autopsy) or non-hemorrhagic.

Stroke is defined as an acute new neurological deficit ending in death or lasting longer than 24 hours, and classified by a physician as a stroke.

  1. Primary hemorrhagic - defined as an intracerebral hemorrhage or subdural hematoma

    1. Intracerebral hemorrhage - Stroke with focal collections of intracerebral blood seen on brain imaging (CT or MRI) or a post-mortem examination, not felt to represent hemorrhagic conversion. Subarachnoid hemorrhage should be included in this category.
    2. Subdural hematoma - High density fluid collection in subdural space on brain images or blood in the subdural space on autopsy.
  2. Non-hemorrhagic cerebral infarction - Stroke without focal collections of intracerebral blood on brain imaging.
  3. Non-hemorrhagic infarction with hemorrhagic conversion - Cerebral infarction with blood felt to represent hemorrhagic
from date of randomization up to usually 4 weeks.
Thrombocytopenia
Time Frame: from date of randomization up to 4 weeks.
Thrombocytopenia is defined as platelet count <50,000 platelets per microliter.
from date of randomization up to 4 weeks.
Device malfunction
Time Frame: from date of randomization up to 4 weeks.
from date of randomization up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leipzig Heart Science gGmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Scientific Corporation
University of Southern Denmark
Heart Center Leipzig - University Hospital
Stiftung Institut fuer Herzinfarktforschung

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Holger Thiele, Prof. Dr. med., Heart Center Leipzig at University of Leipzig
  • Principal Investigator: Jacob Eifer Møller, Prof DMSc, Copenhagen University Hospital Righospitalet
  • Principal Investigator: Christian Hassager, Prof. DMSc, Rigshospitalet, Denmark
  • Principal Investigator: Anne Freund, PD Dr. med., Heart Center Leipzig at Leipzig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DOUBLE-SHOCK Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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