Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic

About 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.

Eligibility criteria

Qualifiers

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).

Dobutamine > 10 ug/kg/min x 15 minutes or

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Protek Solo Transseptal Cannula

Treatment groups

4 Participants
are divided into 1 treatment group

Sponsors and collaborators