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Prosthetic Valve

New Valve Surgery for Heart Valve Defects (MVEFS Trial)

Led By David Morales, MD
Research Sponsored by PECA Labs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

MVEFS Trial Summary

This trial is to test the safety and effectiveness of a new valve for people who need surgery to repair or replace their right ventricular outflow tract. The trial will help determine if the new valve is safe and effective enough to be used in future patients.

Who is the study for?
This trial is for children and young adults under 22 with certain heart conditions needing surgery to fix blood flow from the right ventricle to the pulmonary artery. They must be able to return for follow-ups, have a legal guardian's consent, and not be involved in other drug/device trials or have severe non-cardiac diseases.Check my eligibility
What is being tested?
The MASA Valve Early Feasibility Study tests a new device called MASA Valve in patients requiring surgical reconstruction of the pathway from the heart's right ventricle to the lung arteries (RVOTR). It aims to assess safety and potential benefits as preliminary research before larger studies.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks may include reaction to materials in the device, complications from heart surgery like bleeding or infection, and potential need for future surgeries if issues arise with valve function.

MVEFS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I have severe heart valve issues needing a replacement.
I am younger than 22 years old.

MVEFS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from Device-Related Catheter Intervention
Freedom from Device-Related Reoperation
Freedom from Endocarditis
+4 more
Secondary outcome measures
Freedom from Moderate or Greater Pulmonary Regurgitation
Freedom from Pulmonary Gradient ≥36mmHg
Freedom from device valve failure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

MVEFS Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
This is a single-arm study. All participants in this study will undergo implantation with MASA Valve.

Find a Location

Who is running the clinical trial?

PECA LabsLead Sponsor
David Morales, MDPrincipal InvestigatorCinncinnati Childrens Hospital
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

MASA Valve (Prosthetic Valve) Clinical Trial Eligibility Overview. Trial Name: NCT05452720 — N/A
Tetralogy of Fallot Research Study Groups: Experimental Arm
Tetralogy of Fallot Clinical Trial 2023: MASA Valve Highlights & Side Effects. Trial Name: NCT05452720 — N/A
MASA Valve (Prosthetic Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05452720 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still occurring for this research study?

"No, according to clinicaltrials.gov this medical trial is not presently accepting participants - it was last updated on the 6th of July 2022. However, 16 other trials are actively recruiting new patients at this moment in time."

Answered by AI

Is there an opportunity to participate in this experiment?

"This research is searching for 10 people with truncus arteriosus aged 0-22 that meet specific criteria. These include geographical stability, an informed consent from the legal guardian at their enrolment centre, age under 22 years old, a right ventricular to pulmonary artery mean gradient over 35mm Hg, moderate or severe pulmonary regurgitation (≥3+), and agreement between patient/guardian and physician to return for all necessary follow up visits in compliance with the clinical investigation plan's requirements."

Answered by AI

Are participants below the age of 35 admissible for this trial?

"To be eligible for this medical study, applicants must fall between the ages of 0 and 22. 14 trials are accessible to minors while 11 have been designed specifically with elderly patients in mind."

Answered by AI
~1 spots leftby Apr 2024