Tetrology of FallotMVEFSNCT05452720
MASA Valve Early Feasibility Study
A study testing Surgical Right Ventricular Outflow Tract Reconstruction in people with Tetrology of Fallot and Pulmonary Stenosis, run by PECA Labs at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 0 to 22 years
- Conditions the study is for
- Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus
- What is being tested?
- Surgical Right Ventricular Outflow Tract Reconstruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 May 2023to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Boston Childrens Hospital
Boston, Massachusetts, 02115
David Hoganson, MD, 3146106063, David.Hoganson@cardio.chboston.org
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Joshua Freytag, 513-803-1910, Joshua.Freytag@cchmc.org
David Morales, MD
- Recruiting
Childrens Medical Center Dallas
Dallas, Texas, 75235
Kara Lorduy, Kara.Lorduy@childrens.com
Karl Reyes, MD
- Recruiting
OSF Childrens Hospital of Illinois
Peoria, Illinois, 61637
Drewann Whalen, 217-714-6496, Drewann.S.Whalen@osfhealthcare.org
Harma Terbendian, MD
- Recruiting
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
William Gaynor, MD, gaynor@chop.edu
About this study
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.
Read the 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.
- Conditions
- Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels, Pulmonary Atresia, Ross Procedure
- Being tested
- Surgical Right Ventricular Outflow Tract Reconstruction
- Keywords
- Right Ventricular Outflow Tract Reconstruction, Pulmonary Valve, MASA Valve, Pulmonary Valve Replacement
- Medical subject headings
- Tetralogy of Fallot, Pulmonary Valve Stenosis, Truncus Arteriosus, Persistent, Transposition of Great Vessels, Pulmonary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Right Ventricular Outflow Tract ReconstructionDevice
Surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | This is a single-arm study. All participants in this study will undergo implantation with MASA Valve. Receives: Device: Surgical Right Ventricular Outflow Tract Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device related death
Percentage of patients that have not died related to the device 1 year from implantation
Measured: 1 year
Freedom from Explant
Percentage of patients that have not undergone device explant within 1 year from implantation
Measured: 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
Measured: 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
Measured: 1 year
Freedom from Endocarditis
Percentage of patients that have not had endocarditis within 1 year from implantation
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
Freedom from Pulmonary Gradient ≥36mmHg
Percentage of patients that have a Pulmonary Gradient <= 36mmHg within 1 year from implantation on Echocardiographic assessment
Measured: 1 year
Freedom from device valve failure
Percentage of patients that show do not show valve functional failure on Echocardiographic assessment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start18 May 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetrology of FallotStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PECA Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Morales, MD, Principal investigator, Cinncinnati Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452720
- Sponsor's protocol ID
- G220040
- Acronym
- MVEFS
- Status last verified
- Nov 2024
- First submitted
- 6 Jul 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Only anonymized data is intended to be shared with other clinicians.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MASA Valve Early Feasibility Study
- ClinicalTrials.gov ID
- NCT05452720
- Acronym / sponsor ID
- MVEFS / G220040
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PECA LabsIndustry (pharma, biotech, devices)
- Study start
- 18 May 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: Surgical Right Ventricular Outflow Tract ReconstructionThis is a single-arm study. All participants in this study will undergo implantation with MASA Valve. |
Who may qualify
- Ages
- 0 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Right Ventricular Outflow Tract ReconstructionSurgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve) | Device | Experimental Arm |
Primary outcome
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
3 secondary outcomes
Freedom from Moderate or Greater Pulmonary Regurgitation
Time frame: 1 year
Freedom from Pulmonary Gradient ≥36mmHg
Time frame: 1 year
Freedom from device valve failure
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: Undecided. Only anonymized data is intended to be shared with other clinicians.
Related trials for Tetrology of Fallot
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
Active, not recruitingObservational study
ALTERRA Post-Approval Study
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Morales, MD principal investigator
Cinncinnati Childrens Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Right Ventricular Outflow Tract Reconstruction in people with Tetrology of Fallot and Pulmonary Stenosis, run by PECA Labs at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arush Kalra, MBBS, MS (4123300746, arush@pecalabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from device related death (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.