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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Protek Solo Transseptal Cannula can assist patients with severe pulmonary hypertension and right heart failure in safely reaching a lung transplant. The focus is on whether this device can support the heart and lungs until the transplant occurs. Ideal participants are those awaiting a lung transplant due to pulmonary hypertension and experiencing right heart failure, particularly if they have chronic lung disease or similar conditions. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative device.

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 prior data suggests that the Protek Solo Transseptal Cannula is safe for bridging PH-RVF patients to lung transplant?

Research has shown that the Protek Solo Transseptal Cannula supports the heart during procedures like ECMO, a machine that temporarily takes over heart and lung functions. No specific risks are known for using this cannula beyond the general risks associated with heart-lung machine procedures.

This early phase of the study focuses on safety, with researchers closely monitoring for any side effects. At this stage, the main goal is to assess the treatment's safety and patient tolerance. The cannula is designed to help manage heart problems, offering promise for individuals needing lung transplants due to high blood pressure in the lungs.

Overall, the Protek Solo Transseptal Cannula has shown potential in providing heart support, but further research is needed to fully understand any risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pulmonary hypertension?

Unlike the standard of care for pulmonary hypertension, which often involves medications or surgical interventions like lung transplants, the Protek Solo Transseptal Cannula offers a novel approach by providing right ventricle (RV) support. This treatment is unique because it uses a minimally invasive cannula to enhance blood circulation, especially for patients awaiting lung transplants. Researchers are excited about this method because it could stabilize patients more effectively, potentially reducing the time they spend waiting for a transplant and improving their overall outcomes.

What evidence suggests that the Protek Solo Transseptal Cannula is effective for pulmonary hypertension?

Research has shown that the Protek Solo Transseptal Cannula, which participants in this trial may receive, can help manage right heart failure. This device assists individuals whose right side of the heart is not functioning well. Studies have found that similar devices improve heart function and outcomes for patients needing right heart support. For those with high blood pressure in the lungs, this support is vital. The goal is to stabilize these patients for a safe lung transplant. Overall, early results suggest this method effectively helps patients reach the point where they can undergo a transplant. ^{6 7 8 9 10}

Who Is on the Research Team?

Ian Makey, MD

Principal Investigator

Mayo Clinic

Mohammad E Alomari, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11278424/

The ProtekDuo Cannula: A Comprehensive Review of Efficacy ... The ProtekDuo cannula holds significant potential for future advancements in the field of MCS, offering promising solutions for RVF management.

2. researchgate.net researchgate.net/publication/337382163_A_New_Percutaneous_Approach_to_Treat_Combined_Right_Ventricular_and_Respiratory_Failure_The_Aachen_Cannula

A New Percutaneous Approach to Treat Combined Right ... Our objective is to develop a novel, simplified, and minimally invasive cannula approach to treat both RVF and respiratory failure. Methods: We conceptualized a ...

3. aats.org aats.org/resources/abstract.pdf?abstract=1252297

Outcomes in Peripheral Right Ventricular Device Support Conclusions: Outcomes with PtD are comparable to those of alternative pRVAD cannulation strategies. Of note, there was no significant mobility benefit observed ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39064117/

The ProtekDuo Cannula: A Comprehensive Review of ... Studies have reported favorable outcomes with the ProtekDuo cannula ... support; right ventricular assist device; right ventricular failure.

5. cureus.com cureus.com/articles/297961-percutaneous-right-ventricular-assist-device-for-managing-decompensated-right-heart-failure-in-pulmonary-arterial-hypertension

Percutaneous Right Ventricular Assist Device for Managing ... Temporary RVAD has improved cardiogenic shock, evidenced by decreased RV size, CVP, and improved cardiac output. Budd et al. [14], 2019, Use of ...

6. livanova.com livanova.com/cannulae/en-us/specialty-cannulae

CPB Cannula: ProtekDuo, TandemHeart, ProtekSolo There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The cannula Introducer ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37012224/

Safety and efficacy of ProtekDuo right ventricular assist ... This systematic review aims to evaluate the safety and efficacy of ProtekDuo right ventricular support and evaluate potential clinical variables that can ...

8. mdpi.com mdpi.com/2077-0383/13/14/4077

The ProtekDuo Cannula: A Comprehensive Review of ... The ProtekDuo cannula holds significant potential for future advancements in the field of MCS, offering promising solutions for RVF management.

9. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06770023

Protek Solo Transseptal Cannula in Pulmonary Hypertension ... The purpose of this study is to determine if transseptal extra-corporeal membrane oxygenation (ECMO) can bridge pulmonary hypertension- ...

10. perfusfind.com perfusfind.com/wp-content/uploads/2021/09/MCS-Protek-Cannulae-Brochure_compressed.pdf

Protek Cannulae The ProtekSolo® Transseptal cannula provides a powerful cannulation strategy for unloading the left ventricle.7. The ProtekSolo Transseptal is inserted at ...