MedTrace Logo

MASA Valve Early Feasibility Study

NCT05452720 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-11-06

No results posted yet for this study

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

Interventions

DEVICE

Surgical Right Ventricular Outflow Tract Reconstruction

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

Sponsors & Collaborators

  • PECA Labs

    lead INDUSTRY

Principal Investigators

  • David Morales, MD · Cinncinnati Childrens Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2025-04-01
Completion
2028-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452720 on ClinicalTrials.gov