[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiogenic-shock-ecmo\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiogenic-shock-ecmo":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100616701","pre-emptive-lava-ecmo-for-complex-high-risk-tavr-100616701",false,"NCT07309029","Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR","PROspective Evaluation of Pre-empTive Left Atrial Venoarterial Extra-Corporeal Membrane oxygenaTion for Complex High-risk Transcatheter Aortic Valve Replacement: PROTECT-TAVR","PROTECT-TAVR","Inclusion Criteria:\n\n\\- Patients are required to have either a Class III hemodynamic status OR type B or type C anatomical complexity with Class II (at risk) hemodynamics (Figure 2).\n\n* Hemodynamic Criteria\n\n  * Major Criteria (Class III)\n\n    * Systolic blood pressure \\\u003C90 mmHg or MAP\\\u003C60 mmHg\n    * Need for vasopressors or inotropes to maintain MAP\\>60 mmHg\n    * Evidence of end-organ damage including: acute kidney injury, liver dysfunction, elevated lactate or altered mentation\n  * Minor Criteria (Class II)\n\n    * Left ventricular ejection fraction \\\u003C35%\n    * Pulmonary hypertension (pulmonary artery systolic pressure \\>60 mmHg) with right ventricular dysfunction\n    * Pulmonary capillary wedge pressure \\>30 mmHg\n* Anatomic criteria\n\n  * Major Criteria (Type C)\n\n    * Native or valve-in-valve TAVR requiring single-leaflet modification for a large area of myocardium at risk (e.g. patients with large or dominant left circulation)\n    * Native or valve-in-valve TAVR requiring dual-leaflet modification\n    * Severe bioprosthetic aortic regurgitation\n    * Severe 3-vessel coronary artery disease not amenable to revascularization (SYNTAX score \\>33)\n  * Minor Criteria (Type B)\n\n    * Native or valve-in-valve TAVR requiring single-leaflet modification\n    * Severe commissural misalignment requiring leaflet modification\n    * High-risk for coronary occlusion not amenable to leaflet modification\n    * Critical low-flow low-gradient aortic stenosis (defined as an estimated aortic valve area ≤0.5 cm2)\n\nExclusion Criteria:\n\n* Age \\\u003C18 or pregnant\n\n  * General absolute contraindications to TAVR\n  * Severe peripheral artery disease with infeasibility for veno-arterial extracorporeal membrane oxygenation implantation.\n  * Contraindications to transeptal cannulation (e.g. pre-existing interatrial septum occluder device).\n  * Pre-existing Impella treatment.\n  * Onset of shock \\>12 hours.\n  * Preceding cardiac arrest with prolonged resuscitation (\\>40 minutes).\n  * Other severe concomitant disease with life expectancy \\\u003C6 months.\n  * Participation in another trial with an intervention.\n  * Any class I hemodynamic status\n  * Type A anatomical complexity with class I or II hemodynamic status","ALL","18 Years","100 Years",{"count":21,"type":22},30,"ESTIMATED","30 Days","OBSERVATIONAL","The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk transcatheter aortic valve replacement (TAVR). These patients include adults with severe aortic stenosis who are hemodynamically unstable or at risk of instability due to anatomical complexity. The main questions it aims to answer are:\n\n1. Does pre-emptive LAVA-ECMO reduce the incidence of in-hospital death, intraprocedural cardiac arrest, or emergent cardiac surgery?\n2. What are the safety outcomes related to LAVA-ECMO, including major vascular, bleeding, or cardiac structural complications? -This is a single-arm, prospective, multi-center study with no comparison group.\n\nParticipants will:\n\n* Be screened for eligibility based on hemodynamic status and anatomical complexity\n* Undergo pre-emptive LAVA-ECMO cannulation prior to or during TAVR\n* Receive follow-up assessments at 30 days and 1 year, including clinical evaluation and echocardiography",[27,28,29,30],"Severe Aortic Stenosis","Cardiogenic Shock","Cardiogenic Shock, ECMO","Trans-catheter Aortic Valve Implantation",[32,33,34],"severe aortic stenosis","cardiogenic shock","TAVR","RECRUITING","2025-12-15",{"date":38,"type":39},"2025-12-30","ACTUAL",{"date":41,"type":22},"2026-01-01",{"date":43,"type":22},"2027-06-30",{"name":45,"class":46},"Atlantic Health System","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100600555","phase-3-inhaled-isoflurane-for-sedation-of-invasively-ventilated-patients-with-cardiogenic-shock-on-extracorporeal-membrane-oxygenation-100600555","NCT07099014","Inhaled Isoflurane for Sedation of Invasively Ventilated Patients With Cardiogenic Shock on Extracorporeal Membrane Oxygenation","INSEPTION","Inclusion Criteria:\n\n1. Cardiogenic shock on VA ECMO support for less than 24 hours\n2. Patients on invasive mechanical ventilation receiving propofol and\u002For midazolam at the time of randomization\n3. Invasive mechanical ventilation for less than 48 hours\n4. Expected invasive ventilation and sedation for at least 24h, with a prescribed Richmond agitation scale target within the range of -1 to - 4\n5. Social security registration (AME excluded)\n\nExclusion Criteria:\n\n1. Age \\\u003C18 and \\>75\n2. Pregnancy or breastfeeding\n3. Initiation of ECMO \\>24 hours\n4. Initiation of mechanical ventilation \\>48 hours\n5. Cardiopulmonary Resuscitation \\>20 minutes before randomization\n6. Patient moribund on the day of randomization, SAPS II \\>90\n7. Suspected or proven intracranial hypertension\n8. Corrected QT interval \\> 450ms or with a known or suspected genetic predisposition to malignant hyperthermia\n9. Chronic liver disease defined as a Child-Pugh score of 12-15\n10. Patients ventilated with a tidal volume \\\u003C 4ml\u002Fkg predicted body weight\n11. Participation in another interventional study or being in the exclusion period at the end of a previous study.\n12. Contraindication or allergies to isoflurane, propofol, midazolam or other halogenated anaesthetics","75 Years",{"count":56,"type":22},300,"INTERVENTIONAL",[59],"PHASE3","Midazolam and propofol are the most used intravenous (IV) sedative agents, but their use is associated with well-known adverse effects such as accumulation, myotoxicity, tachyphylaxis, and unpredictable wake-up time.\n\nFor benzodiazepines, an increased tolerance, possible accumulation after long-term use, and an increased risk of acute withdrawal syndrome are reported. In patients on extracorporeal membrane oxygenation (ECMO) for cardiogenic shock, the negative hemodynamic effects of these drugs are a particular matter of concern. Besides the extracorporeal circuit itself may affect the pharmacokinetics of these IV sedatives. Indeed, drug sequestration in ECMO circuits is a well-known phenomenon influenced by drug chemo-physical properties. Given the large surface area of tubing and membrane, considerable quantities of drugs used in ECMO patients may be sequestered over a period, resulting in a significant increase in their volume of distribution. Similarly, frequent hemodilution and organ dysfunction would also contribute to an increase in the volume of distribution.\n\nPropofol, which is lipophilic is significantly sequestrated in the circuit. Consequently, it is commonly observed that patients receiving ECMO have substantially higher sedative and analgesic drug requirements than patients without ECMO.\n\nTo date, there is no ideal concept for analgesia and sedation of patients on ECMO in the ICU.\n\nA drug that sedates effectively but with minimal residual sedation after the end of the administration and without the aforementioned drawbacks of the current agents would be valuable.\n\nInterestingly, a recent randomized controlled non-inferiority trial that randomized 338 patients showed that, compared with propofol, sedation with inhaled anaesthetics was non-inferior. Sedation with inhaled anaesthetics resulted in a higher rate of spontaneous breathing and a shorter wake-up time after 48h of sedation. Indeed, inhaled sedation, which has been associated with reduced opioid consumption and less delirium in ICU patients, is a promising alternative to IV sedation. Moreover, inhaled anaesthetics might be associated with less myocardial injury and lower doses of inotropic support in patients undergoing cardiac surgery. However, to date, the experience with volatile agents remains limited in patients on ECMO.\n\nWe hypothesized that the use of inhaled isoflurane with the Sedaconda anaesthetics conserving device (ACD) in cardiogenic shock patients on ECMO will reduce the mortality and increase the number of ventilation-free days at day 28 following ECMO onset compared to usual IV sedation by propofol and\u002For midazolam.",[29],[63],"Cardiogenic shock, ECMO","NOT_YET_RECRUITING","2025-07-25",{"date":67,"type":39},"2025-08-01",{"date":69,"type":22},"2025-09-15",{"date":71,"type":22},"2029-04-13",{"name":73,"class":46},"Assistance Publique - Hôpitaux de Paris"]