RECRUITING

MASA Valve Early Feasibility Study

Conditions

Tetrology of Fallot Pulmonary Stenosis Truncus Arteriosus Transposition of Great Vessels Pulmonary Atresia Ross Procedure Right Ventricular Outflow Tract Reconstruction Pulmonary Valve MASA Valve Pulmonary Valve Replacement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MASA Valve Early Feasibility Study

Quick Facts

Study Start:2023-05-18

Study Completion:2028-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05452720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Arush Kalra, MBBS, MS

CONTACT

4123300746

arush@pecalabs.com

Doug Bernstein, BS

CONTACT

4125899847

doug@pecalabs.com

Principal Investigator

David Morales, MD

PRINCIPAL_INVESTIGATOR

Cinncinnati Childrens Hospital

Study Locations (Sites)

OSF Childrens Hospital of Illinois

Peoria, Illinois, 61637

United States

Boston Childrens Hospital

Boston, Massachusetts, 02115

United States

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229

United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Childrens Medical Center Dallas

Dallas, Texas, 75235

United States

Collaborators and Investigators

Sponsor: PECA Labs

David Morales, MD, PRINCIPAL_INVESTIGATOR, Cinncinnati Childrens Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-18

Study Completion Date2028-04-01

Study Record Updates

Study Start Date2023-05-18

Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

Right Ventricular Outflow Tract Reconstruction
Pulmonary Valve
MASA Valve
Pulmonary Valve Replacement

Additional Relevant MeSH Terms

Tetrology of Fallot
Pulmonary Stenosis
Truncus Arteriosus
Transposition of Great Vessels
Pulmonary Atresia
Ross Procedure