NCT06770023RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 11 Dec 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Mayo Clinic
- NCT number
- NCT06770023
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 4
- From 11 Dec 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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
- Active infection defined as two of the following WBC \>12,500, positive blood culture, fever
- Thrombolysis within the previous 30 days or known existing coagulopathy such as thrombocytopenia or hemoglobin diseases such as sickle cell anemia or thalassemia
Other
- 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)
- Evidence of acute neurologic injury
- RA thrombus
Who the study is looking for
- 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
- Epinephrine \> 0.5 ug/kg/min x 15 minutes or
- Norepinephrine \> 0.5 ug/kg/min x 15 minutes and have one of the following:
- central venous pressure (CVP) \> 15 mm Hg
- global RV dysfunction on echocardiography defined as one of the following:
- a tricuspid annular plane systolic excursion score of \<14mm
- an RV diameter at base \>42mm
- RV short-axis or midcavity diameter \>35mm
- Lactate greater than 3 mmol/L
- Urine output \< 0.5 ml/kg/hour
- Age \> 18 years old
- BMI \<35
- Informed consent signed by self or legally authorized representative.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.