MASA Valve Early Feasibility Study (MVEFS)
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| ClinicalTrials.gov Identifier: NCT05452720 |
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Recruitment Status :
Recruiting
First Posted : July 11, 2022
Last Update Posted : March 12, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tetrology of Fallot Pulmonary Stenosis Truncus Arteriosus Transposition of Great Vessels Pulmonary Atresia Ross Procedure | Device: Surgical Right Ventricular Outflow Tract Reconstruction | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Device Feasibility |
| Official Title: | MASA Valve Early Feasibility Study |
| Actual Study Start Date : | May 18, 2023 |
| Estimated Primary Completion Date : | April 1, 2024 |
| Estimated Study Completion Date : | April 1, 2028 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental Arm
This is a single-arm study. All participants in this study will undergo implantation with MASA Valve.
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Device: Surgical Right Ventricular Outflow Tract Reconstruction
Surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve) |
- Freedom from device related death [ Time Frame: 1 year ]Percentage of patients that have not died related to the device 1 year from implantation
- Freedom from Explant [ Time Frame: 1 year ]Percentage of patients that have not undergone device explant within 1 year from implantation
- Freedom from Device-Related Reoperation [ Time Frame: 1 year ]Percentage of patients that have not undergone re-operation related to the device within 1 year from implantation
- Freedom from Device-Related Catheter Intervention [ Time Frame: 1 year ]Percentage of patients that have not undergone device related catheter based intervention within 1 year from implantation
- Freedom from Endocarditis [ Time Frame: 1 year ]Percentage of patients that have not had endocarditis within 1 year from implantation
- Freedom from Thrombus [ Time Frame: 1 year ]Percentage of patients that have not had a serious thrombotic event related to the device within 1 year from implantation
- Freedom from Major Hemorrhage [ Time Frame: 1 year ]Percentage of patients that have not had a major bleeding episode related to the device within 1 year from implantation
- Freedom from Moderate or Greater Pulmonary Regurgitation [ Time Frame: 1 year ]Percentage of patients that show less than Moderate Pulmonary Regurgitation within 1 year from implantation on Echocardiographic assessment
- Freedom from Pulmonary Gradient ≥36mmHg [ Time Frame: 1 year ]Percentage of patients that have a Pulmonary Gradient <= 36mmHg within 1 year from implantation on Echocardiographic assessment
- Freedom from device valve failure [ Time Frame: 1 year ]Percentage of patients that show do not show valve functional failure on Echocardiographic assessment
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 0 Years to 22 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
- Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05452720
| Contact: Arush Kalra, MBBS, MS | 4123300746 | arush@pecalabs.com | |
| Contact: Doug Bernstein, BS | 4125899847 | doug@pecalabs.com |
| United States, Illinois | |
| OSF Childrens Hospital of Illinois | Recruiting |
| Peoria, Illinois, United States, 61637 | |
| Contact: Drewann Whalen 217-714-6496 Drewann.S.Whalen@osfhealthcare.org | |
| Principal Investigator: Harma Terbendian, MD | |
| United States, Massachusetts | |
| Boston Childrens Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: David Hoganson, MD 314-610-6063 David.Hoganson@cardio.chboston.org | |
| United States, New York | |
| NewYork-Presbyterian Morgan Stanley Children's Hospital | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Shieca Cenado 646-726-5528 sc5035@cumc.columbia.edu | |
| United States, Ohio | |
| Cincinnati Children's Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Joshua Freytag 513-803-1910 Joshua.Freytag@cchmc.org | |
| Principal Investigator: David Morales, MD | |
| United States, Pennsylvania | |
| Childrens Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: William Gaynor, MD gaynor@chop.edu | |
| United States, Texas | |
| Childrens Medical Center Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Kara Lorduy Kara.Lorduy@childrens.com | |
| Principal Investigator: Karl Reyes, MD | |
| Principal Investigator: | David Morales, MD | Cinncinnati Childrens Hospital |
| Responsible Party: | PECA Labs |
| ClinicalTrials.gov Identifier: | NCT05452720 |
| Other Study ID Numbers: |
G220040 |
| First Posted: | July 11, 2022 Key Record Dates |
| Last Update Posted: | March 12, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Only anonymized data is intended to be shared with other clinicians. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
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Right Ventricular Outflow Tract Reconstruction Pulmonary Valve MASA Valve Pulmonary Valve Replacement |
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Transposition of Great Vessels Pulmonary Valve Stenosis Pulmonary Atresia Truncus Arteriosus, Persistent Tetralogy of Fallot Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases |
Heart Diseases Congenital Abnormalities Heart Valve Diseases Ventricular Outflow Obstruction Vascular Malformations Aortopulmonary Septal Defect Heart Septal Defects |