MASA Valve Early Feasibility Study

NCT05452720 | Recruiting DMC FDA Device

• 1 other identifier: G220040
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Freedom from Moderate or Greater Pulmonary Regurgitation

  1 year

• Freedom from Pulmonary Gradient ≥36mmHg

  1 year

• Freedom from device valve failure

  1 year

Study Arms (1)

Experimental Arm

EXPERIMENTAL

This is a single-arm study. All participants in this study will undergo implantation with MASA Valve.

Device: Surgical Right Ventricular Outflow Tract Reconstruction

Interventions

Surgical Right Ventricular Outflow Tract Reconstruction DEVICE

Surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve)

Experimental Arm

Eligibility Criteria

• Age: 0 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Age \< 22 years
• Patient is geographically stable and willing to return for 1 year follow-up for the trial.
• Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
• 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.

You may not qualify if:

• Patient is in need of or has presence of a prosthetic heart valve at any other position
• Patient has a need for concomitant surgical procedures (non-cardiac)
• Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
• 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)
• Patient has an active endocarditis
• Leukopenia, according to local laboratory evaluation of white blood cell count
• Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
• Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
• Severe chest wall deformity, which would preclude placement of the PV conduit
• Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
• Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
• Patient has chronic inflammatory / autoimmune disease
• Need for emergency cardiac or vascular surgery or intervention
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
• Currently participating, or participated within the last 30 days, in an investigational drug or device study

Sponsors & Collaborators

• PECA Labs: lead

Study Sites (5)

OSF Childrens Hospital of Illinois

Peoria, Illinois, 61637, United States

RECRUITING

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Childrens Medical Center Dallas

Dallas, Texas, 75235, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortopulmonary Septal Defect; Heart Septal Defects; Vascular Malformations

Study Officials

• David Morales, MD

  Cinncinnati Childrens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arush Kalra, MBBS, MS

CONTACT

4123300746; arush@pecalabs.com

Doug Bernstein, BS

CONTACT

4125899847; doug@pecalabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The MASA Valve Early Feasibility Study (MVEFS) is a multi-center, non-randomized, prospective, interventional clinical study to determine the safety and probable benefit of MASA Valve pulmonary valved conduit in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). Each implanted subject will be consented to be followed for a total of 5 years with a post-op, 30 day (30+7), 180 day (180±30) and 1 year follow-up (365 ± 90 days) followed by an annual follow up until 5 years (annual visits with a window of ± 90 days per visit), or until trial closure. Total expected duration of the trial is approximately 5 year from the last enrolled patient. Intermediary results of the trial may be calculated prior to completion of the 1-year (365 ± 90 days) endpoint of all patients.

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: May 18, 2023
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

US (5)