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MASA Valve Early Feasibility Study (MVEFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05452720
Recruitment Status : Recruiting
First Posted : July 11, 2022
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
PECA Labs

Tracking Information
First Submitted Date  ICMJE July 6, 2022
First Posted Date  ICMJE July 11, 2022
Last Update Posted Date March 12, 2024
Actual Study Start Date  ICMJE May 18, 2023
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2022)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2022)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MASA Valve Early Feasibility Study
Official Title  ICMJE MASA Valve Early Feasibility Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Tetrology of Fallot
  • Pulmonary Stenosis
  • Truncus Arteriosus
  • Transposition of Great Vessels
  • Pulmonary Atresia
  • Ross Procedure
Intervention  ICMJE Device: Surgical Right Ventricular Outflow Tract Reconstruction
Surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve)
Study Arms  ICMJE Experimental: Experimental Arm
This is a single-arm study. All participants in this study will undergo implantation with MASA Valve.
Intervention: Device: Surgical Right Ventricular Outflow Tract Reconstruction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2022)		 10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2028
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 0 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arush Kalra, MBBS, MS 4123300746 arush@pecalabs.com
Contact: Doug Bernstein, BS 4125899847 doug@pecalabs.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05452720
Other Study ID Numbers  ICMJE G220040
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Only anonymized data is intended to be shared with other clinicians.
Current Responsible Party PECA Labs
Original Responsible Party Same as current
Current Study Sponsor  ICMJE PECA Labs
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Morales, MD Cinncinnati Childrens Hospital
PRS Account PECA Labs
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP