MASA Valve Early Feasibility Study

Transposition of Great Vessels Clinical Trial

— MVEFS  

Official title:

MASA Valve Early Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452720
• Other study ID #: G220040
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: April 1, 2028

Study information

• Verified date: March 2024
• Source: PECA Labs
• Contact: Arush Kalra, MBBS, MS
• Phone: 4123300746
• Email: arush[@]pecalabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The MASA Valve is a bi-leaflet pulmonary valved conduit. The MASA Valve has an ePTFE conduit and ePTFE leaflets fixtured to the conduit with polypropylene suture. The device has a pad-printed design on the outer conduit surface indicating the valve position and direction of flow. . The MASA Valve is intended to be used to reconstruction the Right Ventricular Outflow Tract (RVOT) and provide a functional pulmonary valve. Once implanted, the MASA Valve provides a pathway for blood from the Right Ventricle (RV) to the Pulmonary Arteries (PAs), while the integrated valve helps to prevent backflow into the RV. The MASA Valve Indications for Use are: The MASA Valve pulmonary valved conduit is indicated for correction or reconstruction of the right ventricular outflow tract (RVOT) in patients aged less than 22 years with any of the following congenital cardiac malformations: - Pulmonary Stenosis - Tetralogy of Fallot - Truncus Arteriosus - Transposition of Great Vessels - Pulmonary Atresia In addition, the MASA Valve is indicated for the replacement of previously implanted, but dysfunctional, pulmonary valves, valved conduits or conduits, as well as for use in the Ross Procedure when the native RVOT is being used to reconstruct the Aorta. Treatments currently available for the above-stated conditions include biologic-tissue-based valved conduits (Homografts and Contegra Glutaraldehyde-fixed Bovine Jugular Vein), Intra-operatively constructed valved conduits made from off-the-shelf vascular grafts and cardiovascular membranes, and non-valved cardiovascular conduits. Based on existing evidence it is believed the potential benefits of MASA Valve outweigh the potential risks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Atresia
• Pulmonary Stenosis
• Pulmonary Valve Stenosis
• Tetralogy of Fallot
• Tetrology of Fallot
• Transposition of Great Vessels
• Truncus Arteriosus
• Truncus Arteriosus, Persistent

Intervention

Device:
• Surgical Right Ventricular Outflow Tract Reconstruction
Surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve)

Locations

Country	Name	City	State
United States	Boston Childrens Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Childrens Medical Center Dallas	Dallas	Texas
United States	NewYork-Presbyterian Morgan Stanley Children's Hospital	New York	New York
United States	OSF Childrens Hospital of Illinois	Peoria	Illinois
United States	Childrens Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
PECA Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device related death	Percentage of patients that have not died related to the device 1 year from implantation	1 year
Primary	Freedom from Explant	Percentage of patients that have not undergone device explant within 1 year from implantation	1 year
Primary	Freedom from Device-Related Reoperation	Percentage of patients that have not undergone re-operation related to the device within 1 year from implantation	1 year
Primary	Freedom from Device-Related Catheter Intervention	Percentage of patients that have not undergone device related catheter based intervention within 1 year from implantation	1 year
Primary	Freedom from Endocarditis	Percentage of patients that have not had endocarditis within 1 year from implantation	1 year
Primary	Freedom from Thrombus	Percentage of patients that have not had a serious thrombotic event related to the device within 1 year from implantation	1 year
Primary	Freedom from Major Hemorrhage	Percentage of patients that have not had a major bleeding episode related to the device within 1 year from implantation	1 year
Secondary	Freedom from Moderate or Greater Pulmonary Regurgitation	Percentage of patients that show less than Moderate Pulmonary Regurgitation within 1 year from implantation on Echocardiographic assessment	1 year
Secondary	Freedom from Pulmonary Gradient =36mmHg	Percentage of patients that have a Pulmonary Gradient <= 36mmHg within 1 year from implantation on Echocardiographic assessment	1 year
Secondary	Freedom from device valve failure	Percentage of patients that show do not show valve functional failure on Echocardiographic assessment	1 year