MASA Valve Early Feasibility Study (MVEFS)

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.

Study Overview

• Status: Recruiting
• Conditions: Transposition of Great Vessels; Pulmonary Atresia; Pulmonary Stenosis; Tetrology of Fallot; Truncus Arteriosus; Ross Procedure
• Intervention / Treatment: Device: Surgical Right Ventricular Outflow Tract Reconstruction

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arush Kalra, MBBS, MS; Phone Number: 4123300746; Email: arush@pecalabs.com
• Study Contact Backup: Name: Doug Bernstein, BS; Phone Number: 4125899847; Email: doug@pecalabs.com

Study Locations

• United States
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Recruiting
      • OSF Childrens Hospital of Illinois
      • Contact: Drewann Whalen; Phone Number: 217-714-6496; Email: Drewann.S.Whalen@osfhealthcare.org
      • Principal Investigator: Harma Terbendian, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Childrens Hospital
      • Contact: David Hoganson, MD; Phone Number: 314-610-6063; Email: David.Hoganson@cardio.chboston.org
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • NewYork-Presbyterian Morgan Stanley Children's Hospital
      • Contact: Shieca Cenado; Phone Number: 646-726-5528; Email: sc5035@cumc.columbia.edu
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital
      • Contact: Joshua Freytag; Phone Number: 513-803-1910; Email: Joshua.Freytag@cchmc.org
      • Principal Investigator: David Morales, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Childrens Hospital of Philadelphia
      • Contact: William Gaynor, MD; Email: gaynor@chop.edu
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • Childrens Medical Center Dallas
      • Contact: Kara Lorduy; Email: Kara.Lorduy@childrens.com
      • Principal Investigator: Karl Reyes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 22 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; This is a single-arm study. All participants in this study will undergo implantation with MASA Valve.	Device: Surgical Right Ventricular Outflow Tract Reconstruction; Surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from device related death	Percentage of patients that have not died related to the device 1 year from implantation	1 year
Freedom from Explant	Percentage of patients that have not undergone device explant within 1 year from implantation	1 year
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
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
Freedom from Endocarditis	Percentage of patients that have not had endocarditis within 1 year from implantation	1 year
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Freedom from Pulmonary Gradient ≥36mmHg	Percentage of patients that have a Pulmonary Gradient <= 36mmHg within 1 year from implantation on Echocardiographic assessment	1 year
Freedom from device valve failure	Percentage of patients that show do not show valve functional failure on Echocardiographic assessment	1 year

Collaborators and Investigators

• Sponsor: PECA Labs
• Investigators: Principal Investigator: David Morales, MD, Cinncinnati Childrens Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pulmonary Valve; Right Ventricular Outflow Tract Reconstruction; MASA Valve; Pulmonary Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Valve Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Vascular Malformations; Heart Septal Defects; Aortopulmonary Septal Defect; Tetralogy of Fallot; Pulmonary Valve Stenosis; Transposition of Great Vessels; Pulmonary Atresia; Truncus Arteriosus, Persistent
• Other Study ID Numbers: G220040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only anonymized data is intended to be shared with other clinicians.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes