MASA Valve Early Feasibility Study

Part of paid clinical trials in Peoria, Illinois.

Sponsor
PECA Labs
Study ID
NCT05452720
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
0 Years - 22 Years
Healthy Volunteers
Not accepted

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)

Study Details

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.

Key Dates

Start date
May 18, 2023
Status verified
Nov 2024
Primary completion
Apr 1, 2025
Completion
Apr 1, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

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

Primary Outcome Measure

Freedom from device related death [ Time Frame: 1 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
OSF Childrens Hospital of IllinoisPeoriaIllinois61637
Drewann Whalen
[email protected]
217-714-6496
Harma Terbendian, MD
Boston Childrens HospitalBostonMassachusetts02115
David Hoganson, MD
[email protected]
3146106063
Cincinnati Children's HospitalCincinnatiOhio45229
Joshua Freytag
[email protected]
513-803-1910
David Morales, MD
Childrens Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
William Gaynor, MD
[email protected]
Childrens Medical Center DallasDallasTexas75235
Karl Reyes, MD

Find similar trials in Peoria, IL

By research site
OSF Childrens Hospital of Illinois· Peoria, ILBoston Childrens Hospital· Boston, MACincinnati Children's Hospital· Cincinnati, OHChildrens Hospital of Philadelphia· Philadelphia, PAChildrens Medical Center Dallas· Dallas, TX

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