Lung TransplantPhase 1NCT06770023
Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension
A Phase 1 study testing Protek Solo Transseptal Cannula in people with Lung Transplant and Pulmonary Hypertension, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Transplant, Pulmonary Hypertension
- What is being tested?
- Protek Solo Transseptal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2026to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Ian Makey, MD, 800-634-1417, makey.ian@mayo.edu
Ian A Makey
About this study
Official title: A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension
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.
Read the detailed description
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.
- Conditions
- Lung Transplant, Pulmonary Hypertension
- Being tested
- Protek Solo Transseptal Cannula
- Keywords
- right heart failure, transseptal, extra-corporeal membrane oxygenation, bridge to transplant
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protek Solo Transseptal CannulaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Lung transplant patients | Experimental | Subjects will be those who are on the transplant list and progress to needing right ventricle (RV) support Receives: Device: Protek Solo Transseptal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival until transplant
Number of subjects to survive between placement of cannula and lung transplant.
Measured: 3 weeks
Secondary outcomes (4)
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.
Measured: 2 months
Extra-corporeal membrane oxygenation (ECMO) support
Number of days after transplant on ECMO support
Measured: 2 months
Dialysis
Number of subjects who need dialysis after transplant
Measured: 2 months
Hospital Discharge
Number of patients that are successfully discharged from the hospital
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start11 Dec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian Makey, Mayo Clinic
- Investigators
- Ian Makey, MD, Principal investigator, Mayo ClinicMohammad E Alomari, MD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770023
- Sponsor's protocol ID
- 24-000660
- Status last verified
- Jul 2026
- First submitted
- 6 Jan 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06770023
- Acronym / sponsor ID
- 24-000660
- Conditions
- Lung Transplant, Pulmonary Hypertension
- Keywords
- right heart failure, transseptal, extra-corporeal membrane oxygenation, bridge to transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplant patients | Experimental | Device: Protek Solo Transseptal CannulaSubjects will be those who are on the transplant list and progress to needing right ventricle (RV) support |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- PH defined as:
- Secondary PH (WHO Group 3) or diagnosis of primary PH (WHO Group 1) (to include Eisenmenger syndrome).
- Failing right ventricle function defined as:
- Age > 18 years old
- BMI <35
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protek Solo Transseptal CannulaThe 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. | Device | Lung transplant patients |
Primary outcome
Survival until transplant
Time frame: 3 weeks
Number of subjects to survive between placement of cannula and lung transplant.
4 secondary outcomes
Number of subjects to experience adverse events
Time frame: 2 months
Extra-corporeal membrane oxygenation (ECMO) support
Time frame: 2 months
Dialysis
Time frame: 2 months
Hospital Discharge
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian Makey, MD principal investigator
Mayo Clinic
Mohammad E Alomari, MD study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Protek Solo Transseptal Cannula in people with Lung Transplant and Pulmonary Hypertension, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian A Makey, MD (9049531048, makey.ian@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival until transplant (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.