| NCT ID | NCT05452720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PECA Labs |
| Condition | Tetrology of Fallot |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-05-18 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2023-05-18 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and/or regulatory clearance submission.
Eligibility Criteria
Inclusion Criteria: 1. At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis. 2. Age \< 22 years 3. Patient is geographically stable and willing to return for 1 year follow-up for the trial. 4. Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled. 5. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits. Exclusion Criteria: 1. Patient is in need of or has presence of a prosthetic heart valve at any other position 2. Patient has a need for concomitant surgical procedures (non-cardiac) 3. Patients with previously implanted pacemaker (including defibrillators) or mechanical valves 4. Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics) 5. Patient has an active endocarditis 6. Leukopenia, according to local laboratory evaluation of white blood cell count 7. Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria 8. Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria 9. Severe chest wall deformity, which would preclude placement of the PV conduit 10. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials 11. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs 12. Patient has chronic inflammatory / autoimmune disease 13. Need for emergency cardiac or vascular surgery or intervention 14. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year 15. Currently participating, or participated within the last 30 days, in an investigational drug or device study 16. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months 17. Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance
Contact & Investigator
David Morales, MD
PRINCIPAL INVESTIGATOR
Cinncinnati Childrens Hospital
Frequently Asked Questions
Who can join the NCT05452720 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 22 Years, studying Tetrology of Fallot. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05452720 currently recruiting?
Yes, NCT05452720 is actively recruiting participants. Contact the research team at arush@pecalabs.com for enrollment information.
Where is the NCT05452720 trial being conducted?
This trial is being conducted at Peoria, United States, Boston, United States, Cincinnati, United States, Philadelphia, United States and 1 additional location.
Who is sponsoring the NCT05452720 clinical trial?
NCT05452720 is sponsored by PECA Labs. The principal investigator is David Morales, MD at Cinncinnati Childrens Hospital. The trial plans to enroll 10 participants.