Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT03431467
Eligibility Criteria:
Inclusion Criteria:
* Cardiogenic shock: Including refractory to conventional therapy, including systolic blood pressure \< 90mm Hg, Cardiac Index \< 1.8 or a cardiac index \< 2.0 on moderate to high doses of inotropes and vasopressors for greater than 30 mins, or systemic signs of tissue hypoxia.
* Post-acute myocardial infarction cardiogenic shock: excluding mechanical complications requiring surgical intervention after extracorpeal membrane oxygenator (ECMO) such as post-ischaemic ventricular septal defect (VSD).
* Drug overdose-induced cardiogenic shock.
* Early graft failure: post orthotropic heart transplantation cardiogenic shock, excluding immediate intra-operative failure.
* Acute on chronic cardiomyopathy with progressive shock and decompensation unresponsive to medical therapies.
Exclusion Criteria:
* Recent Significant Pulmonary Embolus
* Moderate to severe aortic valve insufficiency (AI)
* Ongoing significant sepsis
* Severe pulmonary hypertension \& shock
* Hypothermia
* Post-cardiotomy cardiogenic shock
* Continuous cardiopulmonary resuscitation (CPR) \>20-30 minutes, except if neurological status is satisfactory
* Transfer from outside hospital on VA ECMO or with history of CPR
* Listed for cardiopulmonary transplantation or being evaluated for cardiopulmonary transplantation or permanent mechanical circulatory support
* Known or suspected chronic heart failure with echocardiogram documenting left ventricular diastolic diameter \>6.5cm
* Known or suspected chronic heart failure with echocardiogram documenting left ventricular ejection fraction \< 25%
* Mechanical aortic valve replacement
* Presence of left ventricular thrombus
* Pre-existing Impella 2.5, CP, 3.5 or 5.0
* Cardiogenic shock due to primary respiratory failure
* Mechanical complications requiring surgical intervention after ECMO such as post-ischaemic VSD.
* Severe liver failure
* Active malignancy
* Acute aortic dissection
* Intracranial hemorrhage
* Neurological injury including recent cerebrovascular accident or suspected severe neurologic injury
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03431467
Study Brief:
Protocol Section:
NCT03431467