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

Phase 1

Recruiting

• Conditions: Lung Transplant; Pulmonary Hypertension

• Registration Number: NCT06770023
• Lead Sponsor: Mayo Clinic

Brief 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.

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 Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Study Start: 2025-12-11
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survival until transplant	3 weeks	Number of subjects to survive between placement of cannula and lung transplant.

Secondary Outcome Measures

Name	Time	Method
Number of subjects to experience adverse events	2 months	Adverse events are defined as: death, major bleeding, failure to achieve left atrium access, device migration and stroke.
Extra-corporeal membrane oxygenation (ECMO) support	2 months	Number of days after transplant on ECMO support
Dialysis	2 months	Number of subjects who need dialysis after transplant
Hospital Discharge	2 months	Number of patients that are successfully discharged from the hospital

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States