A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

∙ 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.

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Ian A Makey, MD
makey.ian@mayo.edu
9049531048
Backup
Mohammad E Alomari, MD
alomari.mohammad@mayo.edu
9044283665
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2028-12
Participants
Target number of participants: 4
Treatments
Experimental: Lung transplant patients
Subjects will be those who are on the transplant list and progress to needing right ventricle (RV) support
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov