High-risk PCINCT07622446
Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
A study testing OmniHeart 4.0 Percutaneous Ventricular Assist Device and ECMO in people with High-risk PCI, run by Shanghai Dynaheart Medtech Co., Ltd. at 2 sites in China.
Trial summary
The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd. in providing hemodynamic support for high-risk PCI patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- High-risk PCI
- What is being tested?
- OmniHeart 4.0 Percutaneous Ventricular Assist Device and ECMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 2 sitesChina
- Study dates
- 30 Dec 2024to 31 Dec 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The patient's age is between 18 and 90 years old (inclusive). 2. There is at least one lesion (including primary lesions and restenosis lesions) in the native coronary artery or grafted bypass vessel, and percutaneous coronary intervention (PCI) needs to be performed under hemodynamic support.
- 3. The patient meets one of the following conditions:
- The left ventricular ejection fraction (LVEF) is <=35%, and the vessel to be treated with interventional therapy is an unprotected left main coronary artery lesion or a lesion with only a single remaining open vessel.
- The left ventricular ejection fraction (LVEF) is <=30%, and the vessel to be treated with interventional therapy is a three-vessel coronary artery lesion.
- Among them, a three-vessel coronary artery lesion is defined as follows: there is at least one significant stenosis in each of the three main epicardial coronary arteries (the left anterior descending branch and/or its branches, the left circumflex branch and/or its branches, the right coronary artery and/or its branches). A significant stenosis is defined as a luminal stenosis >= 50% (by visual inspection) or complete occlusion, and at least two vessels have a luminal stenosis >= 70%. For left-dominant coronary arteries, the presence of >= 50% stenosis in both the left anterior descending branch and the proximal left circumflex branch is also regarded as a three-vessel coronary artery lesion.
- 4. The subject or his/her legal guardian is able to understand the purpose of the trial, voluntarily participates in the trial and signs the informed consent form, and is willing to complete the follow-up as required by the trial.
Who cannot join
- 1. Acute ST-segment elevation myocardial infarction within 24 hours before enrollment.
- 2. Cardiac arrest occurred within 24 hours before enrollment and cardiopulmonary resuscitation was required.
- 3. Emergency thrombolysis was performed before enrollment. 4. Cardiogenic shock exists, and cardiogenic shock is defined as follows: (1) Cardiac index (CI) < 2.2 L/min/m² and pulmonary capillary wedge pressure (PCWP) > 15 mmHg; (2) Hypotensive state (systolic blood pressure < 90 mmHg for more than 30 minutes, or systolic blood pressure maintained >= 90 mmHg with the support of vasoactive drugs and/or circulatory assist devices), accompanied by end-organ hypoperfusion (urine output < 30 ml/hour and heart rate > 60 beats/minute, or cold and clammy extremities).
- 5. Left ventricular mural thrombus exists. 6. After aortic valve replacement (including mechanical valves, biological valves), implantation of mechanical circulatory assist devices or cardiac contractile devices.
- 7. Moderate or severe aortic stenosis, moderate or severe aortic insufficiency. 8. Severe peripheral arterial stenosis or occlusion lesions that interfere with the implantation of the test device or the control device.
- 9. Aortic lesions (including aortic aneurysms, aortic dissections, extreme tortuosity or calcification) that interfere with the operation.
Show all 15Show fewer
- 10. Chronic renal insufficiency (serum creatinine >= 4 mg/dl), or dialysis treatment is required.
- 11. Liver insufficiency (liver transaminase and bilirubin levels are more than 3 times the upper limit of the normal range).
- 12. Uncorrected abnormal coagulation function (platelet count <= 75,000/mm³ or INR >= 2.0 or fibrinogen <= 1.5 g/L).
- 13. A history of stroke or transient ischemic attack (TIA) within 1 month before enrollment.
- 14. Allergic or intolerant to iodine contrast agents, heparin, aspirin, ADP receptor inhibitors, and with a history of heparin-induced thrombocytopenia (HIT) in the past.
- 15. Infectious endocarditis exists or is suspected to exist, or there is a systemic active infection.
- 16. Currently participating in other drug/device clinical trials and the primary endpoint has not been reached.
- 17. Pregnant or lactating women, those with a fertility plan within 1 year or those who are unwilling to take effective contraceptive measures.
- 18. Other situations judged by the investigator as not suitable for enrollment that are unforeseen.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Second Affiliated Hospital of Harbin Medical University
Jilin City
Shanghai Dynaheart Medtech Co., Ltd
Shanghai
About this study
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Assess the Efficacy and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device for Hemodynamic Support in Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd. in providing hemodynamic support for high-risk PCI patients. The main questions it aims to answer are:
During the treatment of high-risk PCI, will the application of the OmniHeart 4.0 percutaneous ventricular assist device achieve hemodynamic support that is not inferior to that of ECMO? What medical problems will occur during or after the treatment for participants who receive the OmniHeart 4.0 percutaneous ventricular assist device during high-risk PCI treatment? The researchers will compare the OmniHeart 4.0 percutaneous ventricular assist device with ECMO (a mechanical circulatory support device) using ECMO as the control group to compare the efficacy differences between the two and thereby evaluate the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device in high-risk PCI treatment.
Read more
Participants will:
Be randomly assigned in a 1:1 ratio according to need during high-risk PCI treatment to either the experimental group or the control group. The experimental group will receive the OmniHeart 4.0 percutaneous ventricular assist device for assistance, while the control group will receive the veno-arterial extracorporeal membrane oxygenation (VA-ECMO) device for assistance.
Check-ups and follow-ups will be conducted during the device usage period, at the time of weaning from the device, before discharge, 30 days after surgery, and 90 days after surgery.
The effectiveness endpoint will be evaluated by recording indicators such as the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) free of death within 30 days after surgery.
Read the detailed description
This clinical trial adopts a prospective, multicenter, randomized controlled, non-inferiority design, with a planned enrollment of 254 subjects. It comprehensively evaluates the safety and effectiveness of the investigational device in human subjects, so as to provide sufficient evidence for the marketing approval and registration of the product in China. The rationale for the trial design is specified as follows:
Prospective design: A prospective study can establish clear causal relationships, with unified diagnostic, testing and evaluation criteria for collected data, thus enabling controllable data processing.
Multicenter design: A multicenter trial can accrue a larger number of cases within the same time frame, thereby shortening the duration of the clinical trial; since a multicenter trial is conducted by multiple clinical investigators across different regions and trial sites, its conclusions generally have broad representativeness.
Randomized controlled trial：
- Randomization: In this trial, random grouping was conducted using a central randomization system. The Interactive Web Response System (IWRS) automatically assigned groups according to the sequence of enrollment, thereby reducing the bias in the trial caused by sampling errors. A random table was generated by statisticians or designated personnel. The random table was generated by the SAS software based on the preset seed number and block number. A stratified block randomization design by center was adopted, with a ratio of 1:1 between the treatment group and the control group. After verifying the inclusion and exclusion criteria, the researchers entered the subject information into the central randomization system. The researchers clicked the "Randomization" button in the IWRS system, and the system would automatically generate the random grouping of the subjects and provide the feedback through the network to the researchers indicating whether the subject was assigned to the treatment group or the control group. After receiving the randomization results, the researchers provided corresponding treatment to the subjects according to the respective groups. Throughout the entire trial process, the researchers would not be able to modify the group to which the subjects were assigned. For any subjects who completed randomization but withdrew from the clinical trial before starting treatment, their random number (the random number assigned to the subject) would be retained (the random number assigned to the subject would not be reused). Additionally, for those subjects who prematurely withdrew from the clinical trial, no substitution would be provided.
Comparison: In the routine clinical treatment, ECMO is of certain representativeness. Therefore, this product was selected as the control device for this clinical trial. Using the ECMO product as the control, the efficacy differences between the experimental group and the control group were compared to evaluate the effectiveness and safety of the experimental product.
Non-inferiority: To evaluate the experimental device when used in high-risk PCI treatment, the rate of avoiding major adverse cardiovascular and cerebrovascular events (MACCE) within 30 days after surgery was non-inferior to that of the control device.
- Conditions
- High-risk PCI
- Being tested
- OmniHeart 4.0 Percutaneous Ventricular Assist Device, ECMO
- Keywords
- High-Risk PCI, OmniHeart 4.0, Hemodynamic Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniHeart 4.0 Percutaneous Ventricular Assist DeviceDevice
The experimental group was treated with OmniHeart 4.0 Percutaneous Ventricular Assist Device
ECMODevice
The control group received ECMO treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | OmniHeart 4.0 Percutaneous Ventricular Assist Device Receives: Device: OmniHeart 4.0 Percutaneous Ventricular Assist Device |
| Control group | Active comparator | Extracorporeal membrane oxygenation (ECMO) Receives: Device: ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 30 days after procedure.
MACCE includes: all-cause mortality, stroke/TIA, myocardial infarction, and repeat coronary revascularization.
Measured: 30 days after procedure
Secondary outcomes (5)
The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 90 days after procedure.
MACCE includes: all-cause mortality, stroke/TIA, myocardial infarction, and repeat coronary revascularization.
Measured: 90 days after procedure
The incidence of freedom from major adverse events (MAE) at 30 and 90 days after procedure
MAE includes: all-cause mortality, stroke/TIA, myocardial infarction (MI), repeat coronary revascularization, cardiac or vascular surgery required, acute kidney injury, cardiopulmonary resuscitation/ventricular arrhythmias requiring cardioversion therapy, moderate/severe aortic valve insufficiency, severe hypotension requiring pressor therapy, and failed angioplasty.
Measured: 30 days and 90 days after procedure
The change in left ventricular ejection fraction (LVEF) from the baseline at 30 and 90 days after procedure
Measured: 30 days and 90 days after procedure
The change in New York Heart Association (NYHA) functional classification from the baseline at 30 and 90 days after procedure
Measured: 30 days and 90 days after procedure
Evaluation of device performance (only for the experimental group)
The performance of the device during use is comprehensively evaluated by researchers. The comprehensive evaluation mainly includes: performance of the control unit and performance of the percutaneous implantable catheter pump and infusion components.
Control unit performance evaluation: clarity of interface, operational stability, timeliness of alarms, and ease of operation (for professional personnel only).
Percutaneous implantable catheter pump and infusion component performance evaluation: pushability of the catheter pump, vulnerability of the catheter pump, stability of pump rate and blood volume delivered (under favorable conditions and stable vital signs), ease of removal of the catheter pump, and usability of the catheter pump and infusion components (for professional personnel only).
Measured: Intraprocedure - weaning off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start30 Dec 2024
- Primary completion9 Feb 2026
- 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 High-risk PCIStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Dynaheart Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, China-Japan Union Hospital, Jilin University, Second Hospital of Jilin University, First Affiliated Hospital of Xinjiang Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Chao Yang Hospital, The Second Hospital of Hebei Medical University, Zibo Central Hospital, Henan Provincial Chest Hospital, Wuhan Asia Heart Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622446
- Sponsor's protocol ID
- ShanghaiDynaheart
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 10 Jun 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Assess the Efficacy and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device for Hemodynamic Support in Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
- ClinicalTrials.gov ID
- NCT07622446
- Acronym / sponsor ID
- ShanghaiDynaheart
- Conditions
- High-risk PCI
- Keywords
- High-Risk PCI, OmniHeart 4.0, Hemodynamic Support
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Shanghai Dynaheart Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Second Affiliated Hospital of Harbin Medical University, China-Japan Union Hospital, Jilin University, Second Hospital of Jilin University, First Affiliated Hospital of Xinjiang Medical University, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Chao Yang Hospital, The Second Hospital of Hebei Medical University, Zibo Central Hospital, Henan Provincial Chest Hospital, Wuhan Asia Heart Hospital, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jun 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 objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd. in providing hemodynamic support for high-risk PCI patients. The main questions it aims to answer are:
During the treatment of high-risk PCI, will the application of the OmniHeart 4.0 percutaneous ventricular assist device achieve hemodynamic support that is not inferior to that of ECMO? What medical problems will occur during or after the treatment for participants who receive the OmniHeart 4.0 percutaneous ventricular assist device during high-risk PCI treatment? The researchers will compare the OmniHeart 4.0 percutaneous ventricular assist device with ECMO (a mechanical circulatory support device) using ECMO as the control group to compare the efficacy differences between the two and thereby evaluate the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device in high-risk PCI treatment.
Participants will:
Be randomly assigned in a 1:1 ratio according to need during high-risk PCI treatment to either the experimental group or the control group. The experimental group will receive the OmniHeart 4.0 percutaneous ventricular assist device for assistance, while the control group will receive the veno-arterial extracorporeal membrane oxygenation (VA-ECMO) device for assistance.
Check-ups and follow-ups will be conducted during the device usage period, at the time of weaning from the device, before discharge, 30 days after surgery, and 90 days after surgery.
The effectiveness endpoint will be evaluated by recording indicators such as the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) free of death within 30 days after surgery.
Detailed description
This clinical trial adopts a prospective, multicenter, randomized controlled, non-inferiority design, with a planned enrollment of 254 subjects. It comprehensively evaluates the safety and effectiveness of the investigational device in human subjects, so as to provide sufficient evidence for the marketing approval and registration of the product in China. The rationale for the trial design is specified as follows:
Prospective design: A prospective study can establish clear causal relationships, with unified diagnostic, testing and evaluation criteria for collected data, thus enabling controllable data processing.
Multicenter design: A multicenter trial can accrue a larger number of cases within the same time frame, thereby shortening the duration of the clinical trial; since a multicenter trial is conducted by multiple clinical investigators across different regions and trial sites, its conclusions generally have broad representativeness.
Randomized controlled trial：
- Randomization: In this trial, random grouping was conducted using a central randomization system. The Interactive Web Response System (IWRS) automatically assigned groups according to the sequence of enrollment, thereby reducing the bias in the trial caused by sampling errors. A random table was generated by statisticians or designated personnel. The random table was generated by the SAS software based on the preset seed number and block number. A stratified block randomization design by center was adopted, with a ratio of 1:1 between the treatment group and the control group. After verifying the inclusion and exclusion criteria, the researchers entered the subject information into the central randomization system. The researchers clicked the "Randomization" button in the IWRS system, and the system would automatically generate the random grouping of the subjects and provide the feedback through the network to the researchers indicating whether the subject was assigned to the treatment group or the control group. After receiving the randomization results, the researchers provided corresponding treatment to the subjects according to the respective groups. Throughout the entire trial process, the researchers would not be able to modify the group to which the subjects were assigned. For any subjects who completed randomization but withdrew from the clinical trial before starting treatment, their random number (the random number assigned to the subject) would be retained (the random number assigned to the subject would not be reused). Additionally, for those subjects who prematurely withdrew from the clinical trial, no substitution would be provided.
Comparison: In the routine clinical treatment, ECMO is of certain representativeness. Therefore, this product was selected as the control device for this clinical trial. Using the ECMO product as the control, the efficacy differences between the experimental group and the control group were compared to evaluate the effectiveness and safety of the experimental product.
Non-inferiority: To evaluate the experimental device when used in high-risk PCI treatment, the rate of avoiding major adverse cardiovascular and cerebrovascular events (MACCE) within 30 days after surgery was non-inferior to that of the control device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: OmniHeart 4.0 Percutaneous Ventricular Assist DeviceOmniHeart 4.0 Percutaneous Ventricular Assist Device |
| Control group | Active comparator | Device: ECMOExtracorporeal membrane oxygenation (ECMO) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. The patient's age is between 18 and 90 years old (inclusive). 2. There is at least one lesion (including primary lesions and restenosis lesions) in the native coronary artery or grafted bypass vessel, and percutaneous coronary intervention (PCI) needs to be performed under hemodynamic support.
- The left ventricular ejection fraction (LVEF) is <=35%, and the vessel to be treated with interventional therapy is an unprotected left main coronary artery lesion or a lesion with only a single remaining open vessel.
- The left ventricular ejection fraction (LVEF) is <=30%, and the vessel to be treated with interventional therapy is a three-vessel coronary artery lesion.
- Among them, a three-vessel coronary artery lesion is defined as follows: there is at least one significant stenosis in each of the three main epicardial coronary arteries (the left anterior descending branch and/or its branches, the left circumflex branch and/or its branches, the right coronary artery and/or its branches). A significant stenosis is defined as a luminal stenosis >= 50% (by visual inspection) or complete occlusion, and at least two vessels have a luminal stenosis >= 70%. For left-dominant coronary arteries, the presence of >= 50% stenosis in both the left anterior descending branch and the proximal left circumflex branch is also regarded as a three-vessel coronary artery lesion.
- 4. The subject or his/her legal guardian is able to understand the purpose of the trial, voluntarily participates in the trial and signs the informed consent form, and is willing to complete the follow-up as required by the trial.
Key exclusion criteria (15 listed)
- 1. Acute ST-segment elevation myocardial infarction within 24 hours before enrollment.
- 2. Cardiac arrest occurred within 24 hours before enrollment and cardiopulmonary resuscitation was required.
- 3. Emergency thrombolysis was performed before enrollment. 4. Cardiogenic shock exists, and cardiogenic shock is defined as follows: (1) Cardiac index (CI) < 2.2 L/min/m² and pulmonary capillary wedge pressure (PCWP) > 15 mmHg; (2) Hypotensive state (systolic blood pressure < 90 mmHg for more than 30 minutes, or systolic blood pressure maintained >= 90 mmHg with the support of vasoactive drugs and/or circulatory assist devices), accompanied by end-organ hypoperfusion (urine output < 30 ml/hour and heart rate > 60 beats/minute, or cold and clammy extremities).
- 5. Left ventricular mural thrombus exists. 6. After aortic valve replacement (including mechanical valves, biological valves), implantation of mechanical circulatory assist devices or cardiac contractile devices.
- 7. Moderate or severe aortic stenosis, moderate or severe aortic insufficiency. 8. Severe peripheral arterial stenosis or occlusion lesions that interfere with the implantation of the test device or the control device.
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 |
|---|---|---|
| OmniHeart 4.0 Percutaneous Ventricular Assist DeviceThe experimental group was treated with OmniHeart 4.0 Percutaneous Ventricular Assist Device | Device | Experimental group |
| ECMOThe control group received ECMO treatment. | Device | Control group |
Primary outcome
The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 30 days after procedure.
Time frame: 30 days after procedure
MACCE includes: all-cause mortality, stroke/TIA, myocardial infarction, and repeat coronary revascularization.
5 secondary outcomes
The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 90 days after procedure.
Time frame: 90 days after procedure
The incidence of freedom from major adverse events (MAE) at 30 and 90 days after procedure
Time frame: 30 days and 90 days after procedure
The change in left ventricular ejection fraction (LVEF) from the baseline at 30 and 90 days after procedure
Time frame: 30 days and 90 days after procedure
The change in New York Heart Association (NYHA) functional classification from the baseline at 30 and 90 days after procedure
Time frame: 30 days and 90 days after procedure
Evaluation of device performance (only for the experimental group)
Time frame: Intraprocedure - weaning off
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 10 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OmniHeart 4.0 Percutaneous Ventricular Assist Device and ECMO in people with High-risk PCI, run by Shanghai Dynaheart Medtech Co., Ltd. at 2 sites in China.
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 6 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
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?
The incidence of freedom from major adverse cardiac and cerebrovascular events (MACCE) at 30 days after procedure. (time frame: 30 days after procedure). 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 10 Jun 2026.