A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension

Mayo Clinic1 个研究点分布在 1 个国家目标入组 4 人2026年6月11日

适应症Lung Transplant Pulmonary Hypertension

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Lung Transplant
发起方: Mayo Clinic
入组人数: 4
试验地点: 1
主要终点: Survival until transplant
状态: 招募中
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

详细描述

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. Medicare 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.

注册库

clinicaltrials.gov

开始日期

2026年6月11日

结束日期

2028年12月1日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Mayo Clinic

责任方

Principal Investigator

主要研究者

Ian Makey

Principal Investigator

Mayo Clinic

入排标准

入选标准

•Patients that are listed for lung transplantation and have:
•PH defined as:
•Group 1 Pulmonary arterial hypertension (PAH): Mean pulmonary artery pressure (PAP) ≥ 20 mm Hg, pulmonary capillary wedge pressure (PCWP) \< 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/or 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 \< 2.2 L/min/m\^2 despite continuous infusion of high dose inotropes defined as:
•Inhaled nitric oxide \> 20 ppm and one of the following:
•Dobutamine \> 10 ug/kg/min x 15 minutes or
•Milrinone \> 0.5 ug/kg/min x 120 minutes or

排除标准

•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/dL based on lab data within 24 hours prior to transseptal ECMO initiation; renal creatinine \>4 mg/dLbased 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.