[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06770023":3,"trial-entities:NCT06770023":125,"trial-summary:NCT06770023":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":89,"locations":92,"central_contacts":111,"overall_officials":119,"references":123,"see_also_links":124},"NCT06770023","24-000660","Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension","A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension","RECRUITING","2028-12","2026-07","2026-07-31","2026-12-11","Mayo Clinic","OTHER",true,"The purpose of this study is to determine if transseptal extra-corporeal membrane oxygenation (ECMO) can bridge pulmonary hypertension- right heart failure (PH-RVF) patients to lung transplant safely.","Results will be released as a manuscript once it has gone through the peer review process. Results will be released even in the event of negative outcomes and the release will be hastened if the study is terminated early.\n\nMedicare beneficiaries may be affected by the device under investigation if they are candidates for lung transplant. Since this is such a select group of patients, we do not expect the results of this trial to be generalizable to the general Medicare population.",[19,20],"Lung Transplant","Pulmonary Hypertension",[22],"right heart failure, transseptal, extra-corporeal membrane oxygenation, bridge to transplant","INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},4,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Protek Solo Transseptal Cannula","The Protek Solo Transseptal Cannula ECMO cannula will be placed from the right femoral vein and the drainage cannula will be placed from either the left femoral vein or the right internal jugular vein.",[36],"Lung transplant patients",[38],{"measure":39,"description":40,"timeFrame":41},"Survival until transplant","Number of subjects to survive between placement of cannula and lung transplant.","3 weeks",[43,47,50,53],{"measure":44,"description":45,"timeFrame":46},"Number of subjects to experience adverse events","Adverse events are defined as: death, major bleeding, failure to achieve left atrium access, device migration and stroke.","2 months",{"measure":48,"description":49,"timeFrame":46},"Extra-corporeal membrane oxygenation (ECMO) support","Number of days after transplant on ECMO support",{"measure":51,"description":52,"timeFrame":46},"Dialysis","Number of subjects who need dialysis after transplant",{"measure":54,"description":55,"timeFrame":46},"Hospital Discharge","Number of patients that are successfully discharged from the hospital","ALL","18 Years","80 Years",false,{"inclusion":61,"exclusion":78,"raw_text":88},[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"PH defined as:","Group 1 Pulmonary arterial hypertension (PAH): Mean pulmonary artery pressure (PAP) ≥ 20 mm Hg, pulmonary capillary wedge pressure (PCWP) \\\u003C 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Wood units","Group 3 PH is defined as the presence of chronic lung disease (CLD) and\u002For hypoxia and mean pulmonary artery pressure (PAP) ≥ 20 mm Hg.","Secondary PH (WHO Group 3) or diagnosis of primary PH (WHO Group 1) (to include Eisenmenger syndrome).","Failing right ventricle function defined as:","a cardiac (CI) index \\\u003C 2.2 L\u002Fmin\u002Fm\\^2 despite continuous infusion of high dose inotropes defined as:","Inhaled nitric oxide \\> 20 ppm and one of the following:","Dobutamine \\> 10 ug\u002Fkg\u002Fmin x 15 minutes or","Milrinone \\> 0.5 ug\u002Fkg\u002Fmin x 120 minutes or","Epinephrine \\> 0.5 ug\u002Fkg\u002Fmin x 15 minutes or","Norepinephrine \\> 0.5 ug\u002Fkg\u002Fmin x 15 minutes and have one of the following:","Lactate greater than 3 mmol\u002FL","Urine output \\\u003C 0.5 ml\u002Fkg\u002Fhour","Age \\> 18 years old","BMI \\\u003C35","Informed consent signed by self or legally authorized representative.",[79,80,81,82,83,84,85,86,87],"INTERMACS 1 patients (Critical cardiogenic shock patient who is \"crashing and burning\", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)","End organ failure defined as: hepatic total bilirubin \\>5 mg\u002FdL based on lab data within 24 hours prior to transseptal ECMO initiation; renal creatinine \\>4 mg\u002FdLbased on lab data within the 24 hours prior to transseptal ECMO initiation","Evidence of acute neurologic injury","Active infection defined as two of the following WBC \\>12,500, positive blood culture, fever","RA thrombus","Thrombolysis within the previous 30 days or known existing coagulopathy such as thrombocytopenia or hemoglobin diseases such as sickle cell anemia or thalassemia","Right heart failure from isolated pulmonary embolism","Right heart failure from coronary artery disease or from left heart failure (WHO Type 2)","Congenital forms of pulmonary hypertension such as tetralogy of fallot or pulmonary vein stenosis.","Inclusion Criteria\n\nPatients that are listed for lung transplantation and have:\n\n* PH defined as:\n\n  * Group 1 Pulmonary arterial hypertension (PAH): Mean pulmonary artery pressure (PAP) ≥ 20 mm Hg, pulmonary capillary wedge pressure (PCWP) \\\u003C 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Wood units\n  * Group 3 PH is defined as the presence of chronic lung disease (CLD) and\u002For hypoxia and mean pulmonary artery pressure (PAP) ≥ 20 mm Hg.\n* Secondary PH (WHO Group 3) or diagnosis of primary PH (WHO Group 1) (to include Eisenmenger syndrome).\n* Failing right ventricle function defined as:\n\n  * a cardiac (CI) index \\\u003C 2.2 L\u002Fmin\u002Fm\\^2 despite continuous infusion of high dose inotropes defined as:\n  * Inhaled nitric oxide \\> 20 ppm and one of the following:\n  * Dobutamine \\> 10 ug\u002Fkg\u002Fmin x 15 minutes or\n  * Milrinone \\> 0.5 ug\u002Fkg\u002Fmin x 120 minutes or\n  * Epinephrine \\> 0.5 ug\u002Fkg\u002Fmin x 15 minutes or\n  * Norepinephrine \\> 0.5 ug\u002Fkg\u002Fmin x 15 minutes and have one of the following:\n\n    1. central venous pressure (CVP) \\> 15 mm Hg\n    2. global RV dysfunction on echocardiography defined as one of the following:\n\n       1. a tricuspid annular plane systolic excursion score of \\\u003C14mm\n       2. an RV diameter at base \\>42mm\n       3. RV short-axis or midcavity diameter \\>35mm\n  * Lactate greater than 3 mmol\u002FL\n  * Urine output \\\u003C 0.5 ml\u002Fkg\u002Fhour\n* Age \\> 18 years old\n* BMI \\\u003C35\n* Informed consent signed by self or legally authorized representative.\n\nExclusion Criteria\n\n* INTERMACS 1 patients (Critical cardiogenic shock patient who is \"crashing and burning\", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)\n* End organ failure defined as: hepatic total bilirubin \\>5 mg\u002FdL based on lab data within 24 hours prior to transseptal ECMO initiation; renal creatinine \\>4 mg\u002FdLbased on lab data within the 24 hours prior to transseptal ECMO initiation\n* Evidence of acute neurologic injury\n* Active infection defined as two of the following WBC \\>12,500, positive blood culture, fever\n* RA thrombus\n* Thrombolysis within the previous 30 days or known existing coagulopathy such as thrombocytopenia or hemoglobin diseases such as sickle cell anemia or thalassemia\n* Right heart failure from isolated pulmonary embolism\n* Right heart failure from coronary artery disease or from left heart failure (WHO Type 2)\n* Congenital forms of pulmonary hypertension such as tetralogy of fallot or pulmonary vein stenosis.",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":108},"Mayo Clinic in Florida","Jacksonville","Florida","32224","United States",[100,105],{"name":101,"role":102,"phone":103,"email":104},"Ian Makey, MD","CONTACT","800-634-1417","makey.ian@mayo.edu",{"name":106,"role":107},"Ian A Makey","PRINCIPAL_INVESTIGATOR",{"lat":109,"lon":110},30.33218,-81.65565,[112,115],{"name":113,"role":102,"phone":114,"email":104},"Ian A Makey, MD","9049531048",{"name":116,"role":102,"phone":117,"email":118},"Mohammad E Alomari, MD","9044283665","alomari.mohammad@mayo.edu",[120,121],{"name":101,"affiliation":13,"role":107},{"name":116,"affiliation":13,"role":122},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":126,"biomarkers":128},[20,127],"Right Heart Failure",[],{"nct_id":4,"found":15,"summary":130,"prompt_version":140},{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 4 participants.","completed","Bridge to Lung Transplant with Protek Solo Transseptal Cannula ECMO for Right Heart Failure","This study is looking at whether a device called the Protek Solo Transseptal Cannula can help patients with pulmonary hypertension (high blood pressure in the lungs) and right heart failure safely get to a lung transplant. The Protek Solo Transseptal Cannula is used for a type of life support called ECMO (extra-corporeal membrane oxygenation), which helps the heart and lungs. You might be able to join if you are between 18 and 80 years old, are already on the list for a lung transplant, and have specific types of pulmonary hypertension. The main goal of the study is to see if patients survive until their transplant, measured at 3 weeks. The study plans to enroll 4 patients, and its current status is unclear.","The primary endpoint, survival until transplant, is measured at 3 weeks.",123,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]