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

Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension (NCT06770023) is a Phase 1 interventional studying Lung Transplant and Pulmonary Hypertension, sponsored by Mayo Clinic. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Lung Transplant, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 4 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Inclusion Criteria 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: 1. central venous pressure (CVP) \> 15 mm Hg 2. global RV dysfunction on echocardiography defined as one of the following: 1. a tricuspid annular plane systolic excursion score of \<14mm 2. an RV diameter at base \>42mm 3. 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 - willing to sign a consent form signed by self or legally authorized representative. Exclusion Criteria - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria 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: 1. central venous pressure (CVP) \> 15 mm Hg 2. global RV dysfunction on echocardiography defined as one of the following: 1. a tricuspid annular plane systolic excursion score of \<14mm 2. an RV diameter at base \>42mm 3. 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. Exclusion Criteria * 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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Mayo Clinic in Florida

Jacksonville, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06770023), the sponsor (Mayo Clinic), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06770023 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06770023?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06770023?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06770023. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06770023. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.