ECMO for Pulmonary Hypertension

Overseen By Ian A Makey, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must be taking: Inotropes, Inhaled nitric oxide

Disqualifiers: End organ failure, Acute neurologic injury, Active infection, RA thrombus, Thrombolysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

4 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions the use of high-dose inotropes (medications that help the heart pump more effectively) like Dobutamine, Milrinone, Epinephrine, and Norepinephrine, which might suggest that some medication adjustments could be necessary. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Protek Solo Transseptal Cannula for pulmonary hypertension?

The ProtekDuo cannula, similar to the Protek Solo Transseptal Cannula, has been effectively used in ECMO (a machine that helps with breathing and heart function) to support patients with severe lung and heart issues, such as during lung transplants and heart-lung transplants, by providing consistent oxygenation and heart support. ^{1 2 3 4 5}

Is the Protek Solo Transseptal Cannula safe for use in humans?

The ProtekDuo cannula, used in ECMO treatments, has been safely used in various medical situations, including as a bridge to lung transplants and during heart surgeries. In one study, it was used without complications in most patients, although one patient experienced non-fatal bleeding. Overall, it appears to be generally safe in humans. ^{1 2 4 5 6}

How is the Protek Solo Transseptal Cannula treatment different from other treatments for pulmonary hypertension?

The Protek Solo Transseptal Cannula is unique because it is part of an ECMO (extracorporeal membrane oxygenation) system that provides support by bypassing the right side of the heart and lungs, which is different from traditional drug therapies for pulmonary hypertension that typically focus on dilating blood vessels or reducing blood pressure. ^{1 2 4 5 6}

What is the purpose of this trial?

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.

Research Team

Ian Makey, MD

Principal Investigator

Mayo Clinic

Mohammad E Alomari, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 with a BMI under 35, listed for lung transplant due to various types of pulmonary hypertension and failing right heart function. They must meet specific criteria related to heart performance and organ function. Excluded are those with blood clots in the right atrium, active infections, severe end-organ failure, recent thrombolysis or coagulopathy.

Inclusion Criteria

Informed consent signed by self or legally authorized representative

I am older than 18 years.

BMI <35

Exclusion Criteria

I have a blood clot in my right atrium.

I do not have any current infections.

INTERMACS 1 patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transseptal ECMO as a bridge to lung transplant

3 weeks

Continuous monitoring during ECMO support

Post-transplant ECMO Support

Participants remain on ECMO support after lung transplant

2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Treatment Details

Interventions

• Protek Solo Transseptal Cannula

Trial Overview The study tests if using the Protek Solo Transseptal Cannula for trans-septal ECMO can safely help patients with pulmonary hypertension-related right heart failure survive until they can get a lung transplant.

Participant Groups

Group I: Lung transplant patients Experimental Treatment 1 Intervention

Subjects will be those who are on the transplant list and progress to needing right ventricle (RV) support

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The ProtekDuo cannula used in VV-ECMO provides a unique method for bypassing blood from the right atrium to the pulmonary artery, which is crucial for patients experiencing severe respiratory failure, especially during the COVID-19 pandemic.

An innovative percutaneous approach was successfully implemented to restore blood flow and oxygenation in a patient using the ProtekDuo cannula, demonstrating a potential solution for managing complications without the need for circuit replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Percutaneous Snare-Assisted Manipulation and Repositioning of a ProtekDuo Cannula in a COVID-19 Acute Respiratory Distress Syndrome. Haq, SH., Shah, SR., Golzarian, H., et al.[2023]

The ProtekDuo veno-venous ECMO system has shown improved outcomes in patients with acute heart decompensation by effectively decompressing the right heart and providing consistent gas exchange.

Two successful cases demonstrated the use of ProtekDuo ECMO as a bridge to lung transplantation and heart-lung transplantation, highlighting its potential in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ProtekDuo as a bridge to lung transplant and heart-lung transplant. Sinha, N., Goodarzi, A., Akku, R., et al.[2021]

The study demonstrated that percutaneous transseptal ECMO cannulation can effectively relieve pulmonary hypertension in a right ventricular failure model, with successful access achieved using intracardiac echocardiography in most cases.

Mean arterial pressure improved significantly with higher ECMO flow rates, indicating that this method may provide a viable temporary solution for patients awaiting lung transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Transseptal Extracorporeal Membrane Oxygenation to Rescue a Failing Right Ventricle in an Animal Model. Castillo-Larios, R., Pollak, PM., Chaudhary, S., et al.[2023]

The ProtekDuo cannula can be safely used for remote cannulation and transport of patients with severe heart failure, as demonstrated in two cases involving ambulance and helicopter transport without complications.

This study is the first to report on the use of the ProtekDuo cannula in such transport scenarios, suggesting it may be a viable alternative to traditional venoarterial ECMO for managing acute right and biventricular heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using the ProtekDuo cannula in V-P ECMO and PROpella configurations during ground and air transport. Maybauer, MO., Reaves, ZR., Brewer, JM.[2022]

A new patient-tailored strategy using the ProtekDuo cannula for cardiopulmonary bypass during LVAD implantation in ECMO patients was successfully implemented in six patients, showing feasibility and safety with no 30-day mortality.

The approach allowed for effective temporary right ventricular support, with only one case of non-fatal bleeding, indicating that this method could be a promising option for high-risk patients undergoing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planned Combo Strategy for LVAD Implantation in ECMO Patients: A Proof of Concept to Face Right Ventricular Failure. Tarzia, V., Ponzoni, M., Pittarello, D., et al.[2022]

The Protek DuoTM cannula was successfully used for peripheral veno-venous extra-corporeal life support (ECLS) in a 53-year-old male patient who had undergone implantation of a total artificial heart for biventricular failure.

The patient required ECLS for six days due to post-operative respiratory dysfunction, demonstrating the cannula's potential effectiveness in managing critical respiratory support in patients with severe cardiac conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veno-venous extracorporeal membrane oxygenation using an innovative dual-lumen cannula following implantation of a total artificial heart. Youdle, J., Penn, S., Maunz, O., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Novel Percutaneous Snare-Assisted Manipulation and Repositioning of a ProtekDuo Cannula in a COVID-19 Acute Respiratory Distress Syndrome. [2023]

2. Denmark pubmed.ncbi.nlm.nih.gov

ProtekDuo as a bridge to lung transplant and heart-lung transplant. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Transseptal Extracorporeal Membrane Oxygenation to Rescue a Failing Right Ventricle in an Animal Model. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility of using the ProtekDuo cannula in V-P ECMO and PROpella configurations during ground and air transport. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Planned Combo Strategy for LVAD Implantation in ECMO Patients: A Proof of Concept to Face Right Ventricular Failure. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Veno-venous extracorporeal membrane oxygenation using an innovative dual-lumen cannula following implantation of a total artificial heart. [2017]